Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 32
- Latest Decision
- 1989-06-23
Clearances · page 105 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K893568 | ARGENCO 56 TYPE IV DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-23 |
| K892455 | KULZER ADHESIVE CEMENT | Kulzer, Inc. | EBF | Class II | 1989-06-22 |
| K893458 | FIBEROPTIC HEADLIGHT SYSTEM | Cuda Products Co. | EBA | Class I | 1989-06-22 |
| K893255 | SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE | American Orthodontics | DYH | Class II | 1989-06-21 |
| K893567 | ARGENCO 52 TYPE IV DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-20 |
| K893563 | ARGENCO 42 TYPE IV DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-20 |
| K893554 | ARGENCO 60 TYPE IV DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-20 |
| K893564 | ARGENCO 30 TYPE IV DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-20 |
| K892419 | NPG 2 BASE METAL ALLOY | Aalba Dent, Inc. | EJF | Class I | 1989-06-16 |
| K892454 | KULZER INLAY SYSTEM | Kulzer, Inc. | EBF | Class II | 1989-06-16 |
| K891694 | THE SMILE MACHINE | Brilliant Industries, Inc. | JEQ | Class I | 1989-06-16 |
| K892452 | PALASEAL(R) | Kulzer, Inc. | EBI | Class II | 1989-06-16 |
| K892388 | THE TONGUE CLEANER | Rajiv R. Shah | LCN | Class I | 1989-06-16 |
| K890433 | IMPLANT PARALLELING DEVICE (I.P.D.) | J.E. Josephson, D.M.D. | EFB | Class I | 1989-06-16 |
| K893434 | ARGENCO 20 TYPE III DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K893413 | ARGENCO 40 TYPE III DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K893386 | ARGENCO 62 TYPE III DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K893441 | ARGENCO 50 TYPE III DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K893345 | ARGELITE 50 (DENTAL ALLOY FOR PORCELAIN APPLI.) | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K892456 | KULZER TRANSLUX EC | Kulzer, Inc. | EBZ | Class II | 1989-06-14 |
| K891600 | ARGEDENT 88, DENTAL ALLOY FOR PORCELAIN) | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K893382 | ARGENCO 63 TYPE III DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K892910 | ARGELITE 76SF+ DENTAL ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K893384 | ARGENCO 83 TYPE I DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K893385 | ARGENCO 77 TYPE II DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K893383 | ARGENCO 75 TYPE III DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K893443 | ARGENCO 60 TYPE III DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K893381 | ARGENCO 71 TYPE II DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K893442 | ARGENCO 58 TYPE III DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K892264 | ORALCHEK SUPER-SOFT BRUSH | Pfizer, Inc. | EFW | Class I | 1989-06-14 |
| K893444 | ARGENCO 46 TYPE III DENTAL GOLD ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-14 |
| K892811 | ARGELITE 54B | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-12 |
| K893227 | ARGENCO W+ | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-12 |
| K893037 | NO-MIX 30 ORTHODONTIC BONDING SYSTEMS | American Orthodontics | DYH | Class II | 1989-06-12 |
| K892373 | DENTAL PLASTIC BITE FORK | Texapol Corp. | EJP | Class I | 1989-06-12 |
| K891612 | DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. | Implant Innovations International, Inc. | EFD | Class I | 1989-06-12 |
| K890355 | DENTAL X-RAY BITE BLOCK | Bite-A-Block | EGZ | Class I | 1989-06-12 |
| K892704 | GEM II ORTHODONTIC BRACKET | Ormco Corp. | EJF | Class I | 1989-06-12 |
| K891698 | ZAROLAN, DUALAN, TITAN AND SUPERON | Dent Zar, Inc. | EBF | Class II | 1989-06-09 |
| K891536 | ENAMEL MICROABRASION COMPOUND | Premier Dental Products Co. | EJR | Class I | 1989-06-09 |
| K893237 | ARGENCO W | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-07 |
| K892003 | ABRAKADABRA - DENTAL ADHESIVE SYSTEM | Parkell | KLE | Class II | 1989-06-07 |
| K890043 | DENTCLEAN CONCENTRATED DENTURE CLEANSER | K-P Co. | EFT | Class I | 1989-06-07 |
| K892144 | MODIFIED ULTIMA LITE | Deringer-Ney, Inc. | EJT | Class II | 1989-06-07 |
| K893238 | ARGENCO WLF | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-06 |
| K893010 | ARGELITE 54+ | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-06 |
| K892907 | CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL RESTOR. | Deringer-Ney, Inc. | EJT | Class II | 1989-06-06 |
| K893228 | ARGENCO W-LITE | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-06 |
| K893244 | ARGENCO WR+ | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-06 |
| K892893 | SDI POLYCARBONATE CROWN, SCHEIN'S | Svenska Dental Instruments AB | ELZ | Class I | 1989-06-06 |
| K891216 | DENTAL EQUIPMENT PROTECTION DEVICES | Pro-Safe Professional Linens, Inc. | EAZ | Class I | 1989-06-02 |
| K892709 | ARGEDENT 62 DENTAL ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-01 |
| K892810 | ARGEDENT 35SF | Argen Precious Metals, Inc. | EJT | Class II | 1989-06-01 |
| K892335 | ARGEDENT 74 DENTAL ALLOY FOR PORCELAIN APPLI. | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-31 |
| K891064 | ESPE CAPMIX | Espe GmbH (Us) | EFD | Class I | 1989-05-30 |
| K891989 | ARGEDENT 52 (DENTAL ALLOY) | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-30 |
| K891020 | ESPE TULUX-CEM | Espe GmbH (Us) | EBF | Class II | 1989-05-26 |
| K892662 | ARGEDENT 87 | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-24 |
| K893012 | ARGELITE 60+ | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-24 |
| K884652 | OCTYLDENT | Crx Medical, Inc. | EMA | Class II | 1989-05-24 |
| K891006 | QUICK-TIP (DENTAL OPERATORY UNIT) | Bernard S Esrock | EIA | Class I | 1989-05-24 |
| K892894 | S-FILE, S-FINDER, S-ENGINE FILE | Svenska Dental Instruments AB | EKS | Class I | 1989-05-24 |
| K892909 | ARGELITE 80SF+ DENTAL ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-22 |
| K892814 | ARGEDENT 45 | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-22 |
| K892815 | ARGEDENT 45SF | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-19 |
| K892813 | ARGELITE 60 | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-19 |
| K891320 | ARGELITE 58P (DENTAL ALLOY) | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-19 |
| K892816 | ARGEDENT 38 | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-19 |
| K893009 | ARGELITE SR+ | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-19 |
| K893011 | ARGIPAL | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-19 |
| K892812 | ARGELITE 75+6 | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-19 |
| K892708 | ARGEDENT Y-86 DENTAL ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-19 |
| K891463 | ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM | Confi-Dental Products Co. | EBF | Class II | 1989-05-19 |
| K893008 | ARGELITE 54 | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-19 |
| K892908 | ARGELITE 80SF DENTAL ALLOY | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-19 |
| K891455 | DENTIN PRIMER | Dentsply Intl. | KLE | Class II | 1989-05-18 |
| K892234 | ARGEDENT 75 | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-18 |
| K892239 | DENTAL HAND INSTRUMENTS | Implant Support Systems, Inc. | EKJ | Class I | 1989-05-18 |
| K884732 | SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM | Bio-Interfaces, Inc. | DZE | Class II | 1989-05-18 |
| K891464 | RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4 | Confi-Dental Products Co. | DYH | Class II | 1989-05-18 |
| K885231 | KITCHIN DENTAL ABCESS DRAIN | Kitchin, Inc. | EIE | Class I | 1989-05-16 |
| K891911 | ARGEDENT 52SF | Argen Precious Metals, Inc. | EJT | Class II | 1989-05-11 |
| K891775 | MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES | American Orthodontics | EJF | Class I | 1989-05-11 |
| K892261 | RUBBER DAM CLAMPS/FORCEPS | Zinnanti Surgical Instruments, Inc. | EKJ | Class I | 1989-05-10 |
| K890662 | PENT CAPS | Jeneric/Pentron, Inc. | EJJ | Class II | 1989-05-09 |
| K890682 | OROSPHERE PLUS | Jeneric/Pentron, Inc. | EJJ | Class II | 1989-05-05 |
| K890600 | HYDRODENT ANTIPLAQUE SYSTEM | Hydrodent Laboratories, Inc. | EFS | Class I | 1989-05-05 |
| K890681 | OROSPHERE HCDP | Jeneric/Pentron, Inc. | EJJ | Class II | 1989-05-02 |
| K892260 | PRICHARD PERIOSTEAL RETRACTOR #3 | Zinnanti Surgical Instruments, Inc. | EKJ | Class I | 1989-05-02 |
| K891599 | FILAFLEX ORTHODONTIC WIRE | American Orthodontics | EJF | Class I | 1989-05-02 |
| K891054 | NON-STERILE GAUZE SPONGE | Dispomed, Inc. | KHR | Class I | 1989-05-01 |
| K890830 | DENTURE RESIN | G-C Intl. Corp. | EBI | Class II | 1989-05-01 |
| K890834 | NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC | Scientific Pharmaceuticals, Inc. | DYH | Class II | 1989-05-01 |
| K892255 | DENTAL ROOT ELEVATOR | Zinnanti Surgical Instruments, Inc. | EKO | Class II | 1989-05-01 |
| K890536 | JASPER JUMPER KIT | American Orthodontics | EJF | Class I | 1989-05-01 |
| K891617 | INSERTION TOOLS | Implant Innovations International, Inc. | DZE | Class II | 1989-05-01 |
| K891140 | OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT | Coe Laboratories, Inc. | EBC | Class II | 1989-05-01 |
| K890712 | ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS | Advantage Dental Products, Inc. | EBH | Class I | 1989-04-25 |
| K890740 | FRS LITE FLUORIDE RELEASING SEALANT | Ormco Corp. | DYH | Class II | 1989-04-25 |
| K884304 | ORTHO PATIENT CHAIR | Halton Furniture Mfg. | KLC | Class I | 1989-04-25 |
12,679 clearances in the Dental panel. Data: openFDA.