Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 56
- Latest Decision
- 1982-11-10
Clearances · page 119 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K823097 | NATURELLE | Bauer, Cheng & Associates, Inc. | EJS | Class II | 1982-11-10 |
| K823084 | CHALLENGER | Bauer, Cheng & Associates, Inc. | EJS | Class II | 1982-11-10 |
| K822969 | GENERATION 5 LINKOW BLADE IMPLANTS | Leonard P. Linkow, D.D.L. | NRQ | Class II | 1982-11-04 |
| K823008 | NOVAREX | Jeneric Ind. | EJH | Class II | 1982-11-03 |
| K822464 | OBTURATION GUTTA | U.S. Shizai Corp. | EKA | Class I | 1982-11-03 |
| K822956 | G CAST | J. Aderer, Inc. | EJT | Class II | 1982-10-26 |
| K822947 | NEPTUNE | Jeneric Ind. | EJH | Class II | 1982-10-26 |
| K822951 | SPHEREX E.C.T. | Jeneric Ind. | EJJ | Class II | 1982-10-26 |
| K822957 | PURCAST | J. Aderer, Inc. | EJH | Class II | 1982-10-26 |
| K822949 | RX SFC | Jeneric Ind. | EJT | Class II | 1982-10-22 |
| K822948 | RX BIOCAST | Jeneric Ind. | EJH | Class II | 1982-10-22 |
| K822950 | RX UNIVERSAL | Jeneric Ind. | EJS | Class II | 1982-10-22 |
| K822793 | PIO ROOT CANAL INDICATOR | National Patent Development Corp. | EIL | Class I | 1982-10-22 |
| K822896 | CAVIDRY | Parker Laboratories, Inc. | EJH | Class II | 1982-10-22 |
| K822894 | DIABRITE | Antraco, Inc. | EJR | Class I | 1982-10-18 |
| K822869 | COMMAND BONDING RESIN/GLAZE/OPAQUER | Sybron Corp. | EBD | Class II | 1982-10-13 |
| K822654 | CURING LIGHT | Venture Technology, Inc. | EBZ | Class II | 1982-10-04 |
| K822722 | CROWN S BRIDGE RESIN | Rohm and Haas Co. | EBG | Class II | 1982-09-30 |
| K822714 | CONCLUDE COMPOSITE LUTING CEMENT | 3M Company | EBD | Class II | 1982-09-28 |
| K822452 | PROTEMP | Espe GmbH (Us) | EBG | Class II | 1982-09-28 |
| K822740 | K30000 DENTAL CHAIR | Kaycor Intl., Ltd. | KLC | Class I | 1982-09-28 |
| K822621 | ROOT CANAL FILES, TYPE K | Union Broach, Div. Moyco Industries, Inc. | EKS | Class I | 1982-09-28 |
| K822620 | ROOT CANAL REAMERS, TYPE K | Union Broach, Div. Moyco Industries, Inc. | EKP | Class I | 1982-09-28 |
| K822265 | FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS | Kelleher Corp. | EBA | Class I | 1982-09-28 |
| K822622 | ROOT CANAL FILES, TYPE H (HEDSTROM | Union Broach, Div. Moyco Industries, Inc. | EKS | Class I | 1982-09-28 |
| K822142 | DIAGLAZE | Antraco, Inc. | EJR | Class I | 1982-09-14 |
| K822450 | AURAFILL* DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | EBF | Class II | 1982-09-14 |
| K822453 | VISIO-OPAQUER | Espe GmbH (Us) | EBF | Class II | 1982-09-14 |
| K822568 | EAR PROBES | Kelleher Corp. | EKL | Class I | 1982-09-14 |
| K822642 | OPTILUX & VISILUX DENTAL PHOTO LAMP | Demetron Research Corp. | EBZ | Class II | 1982-09-14 |
| K822610 | PRECAPSULED DENTAL AMALGAM | Syntex Dental Products, Inc. | DZS | Class I | 1982-09-14 |
| K822451 | AURAFILL* DENTAL RESTORATIVE BONDING AG. | Johnson & Johnson Professionals, Inc. | KLE | Class II | 1982-09-07 |
| K822412 | REINFORCING PIN | Filhol | EBL | Class I | 1982-08-30 |
| K821025 | NEODONTICS DENTAL IMPLANT | Neodontics, Inc. | DZE | Class II | 1982-08-30 |
| K822419 | NEW CROWN AND BRIDGE ALLOY NO. DW196 | Williams Gold Refining Co., Inc. | EJS | Class II | 1982-08-30 |
| K822001 | FRI ALIT DENTAL IMPLANT -TUBING | Friedrichsfeld GmbH | DZE | Class II | 1982-08-19 |
| K822094 | DENTAL MATRIX BAND | Dentsply Intl. | DZN | Class I | 1982-08-16 |
| K821685 | TOM'S NATURALLY WAXED FLOSSING TAPE | Tom'S of Maine, Inc. | JES | Class I | 1982-08-12 |
| K821752 | SYNTHOGRAFT LG-AUGMENTATION & BONE FILL | Depuy, Inc. | LYC | Class II | 1982-08-12 |
| K821782 | BEACH ANESTHETIC SYRINGE CARTR. TYPE | Pacific Dental Corp. | EJI | Class II | 1982-07-20 |
| K821971 | VALULINE* AMALGAM ALLOY | Johnson & Johnson Professionals, Inc. | EJJ | Class II | 1982-07-20 |
| K821895 | AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR | American Midwest | EBF | Class II | 1982-07-16 |
| K821798 | 82 ALLOY | J. Aderer, Inc. | EJS | Class II | 1982-07-13 |
| K821832 | DEGUCAST U | J. Aderer, Inc. | EJS | Class II | 1982-07-06 |
| K821785 | BEACH AMALGAM CARVER | Pacific Dental Corp. | EKH | Class I | 1982-07-06 |
| K821789 | BEACH CURETTE NO. 2 AND NO. 3 T.G. | Pacific Dental Corp. | EMS | Class I | 1982-07-06 |
| K821787 | BEACH SURGICAL PLIERS NON-HOOK | Pacific Dental Corp. | EJY | Class I | 1982-07-06 |
| K821780 | BEACH EXPLORER NO. 23T.G. | Pacific Dental Corp. | EKB | Class I | 1982-07-06 |
| K821810 | PIEZON ULTRASONIC SCALER | Healthco, Inc. | ELC | Class II | 1982-07-06 |
| K821788 | BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT | Pacific Dental Corp. | EMJ | Class I | 1982-07-06 |
| K821824 | TEM-STIK | Coralite Dental Products, Inc. | EMA | Class II | 1982-07-06 |
| K821786 | BEACH SCALERS | Pacific Dental Corp. | EMN | Class I | 1982-07-06 |
| K821790 | BEACH EXCAVATOR'S NO. 1 & NO. 2 | Pacific Dental Corp. | EKD | Class I | 1982-07-06 |
| K821784 | BEACH GINGIVAL RETRACTION INSTR. TYPE B | Pacific Dental Corp. | EIG | Class I | 1982-07-06 |
| K821778 | BEACH DRESSING PLIER | Pacific Dental Corp. | EFL | Class I | 1982-07-06 |
| K821779 | BEACH AMALGAM CARRIER, GUN TYPE | Pacific Dental Corp. | EKJ | Class I | 1982-07-06 |
| K821777 | BEACH MOUTH MIRROR | Pacific Dental Corp. | EAX | Class I | 1982-07-06 |
| K821781 | BEACH FORCEP NO. 150 AND NO. 151 | Pacific Dental Corp. | EMG | Class I | 1982-07-02 |
| K821686 | DENSCO PROPHY ANGLE | Teledyne Densco | EGS | Class I | 1982-06-25 |
| K821715 | AM-40 SYSTEM | American Midwest | EFB | Class I | 1982-06-25 |
| K821739 | J. MORITA FLEX M-3 TORX HARDPIECE | Pacific Dental Corp. | EKX | Class I | 1982-06-25 |
| K821629 | FIXIDENT | Moyco Industries, Inc. | JET | Class I | 1982-06-14 |
| K821572 | DUALLOR 'R' | J. Aderer, Inc. | EJS | Class II | 1982-06-14 |
| K821581 | DEN TEMP | Majestic Drug Co., Inc. | EMB | Class I | 1982-06-14 |
| K821590 | PORS-ON | J. Aderer, Inc. | EJS | Class II | 1982-06-14 |
| K821625 | ENDODONTIC PAPERPOINTS | Roeko | EKN | Class I | 1982-06-14 |
| K821444 | COLORED WEDGE USED TO SEPARATE TEETH | Moyco Industries, Inc. | DZN | Class I | 1982-06-14 |
| K820998 | DENTRON-DIRECT-TRAY | Dentron, Inc. | EBH | Class I | 1982-06-10 |
| K820997 | DENTRON-EXACT - TRAY | Dentron, Inc. | EBH | Class I | 1982-06-10 |
| K821446 | DEGUDENT 14 | J. Aderer, Inc. | EJT | Class II | 1982-06-09 |
| K821458 | DYNAMIC FUNTIONAL POSITIONER | Dynamic Functional Positioner, Inc. | KMY | Class I | 1982-06-09 |
| K821407 | DEVA M | J. Aderer, Inc. | EJS | Class II | 1982-06-09 |
| K821521 | STABILOR NF | J. Aderer, Inc. | EJT | Class II | 1982-06-09 |
| K821510 | A THENIUM | Williams Gold Refining Co., Inc. | EJS | Class II | 1982-06-09 |
| K821484 | DAWN LOW SPEED HANDPIECE SYSTEM | Young Dental Manufacturing Co. 1, LLC | EFB | Class I | 1982-06-09 |
| K821217 | REIGNING DENTURE | Oki Shiks USA , Ltd. | EBI | Class II | 1982-06-07 |
| K821221 | DENTAL IMPRESSION MATERIAL | Crown Delta Corp. | ELW | Class II | 1982-06-07 |
| K821226 | DENTAL AMALGAM ALLOY | Dental Alloyers Intl., Inc. | EJJ | Class II | 1982-06-07 |
| K821613 | E.G. BRIDGE GOLD | J. Aderer, Inc. | EJT | Class II | 1982-06-04 |
| K821292 | TONSIL SCISSORS 7 | Conphar, Inc. | EGN | Class I | 1982-05-28 |
| K821275 | MAYO SCISSOR STRAIGHT 5 1/2 | Conphar, Inc. | EGN | Class I | 1982-05-28 |
| K821285 | SPLINTER FORCEPS 4 1/2 | Conphar, Inc. | EFL | Class I | 1982-05-28 |
| K821294 | TONSIL SCISSORS STRAIGHT 5 1/2 | Conphar, Inc. | EGN | Class I | 1982-05-28 |
| K821326 | CUTTER BOND POLYCARBOXYLATE CEMENT | Cutter Laboratories, Inc. | EMA | Class II | 1982-05-28 |
| K821282 | THUMB DRESSING FORCEPS 5 | Conphar, Inc. | EFL | Class I | 1982-05-28 |
| K821284 | ADSON FORCEPS 4 3/4 | Conphar, Inc. | EFL | Class I | 1982-05-28 |
| K821230 | SOFTIC 49 | The Healthcare Group Laboratories, Inc. | EBI | Class II | 1982-05-28 |
| K821276 | MAYO SCISSOR CURYED 5 1/2 | Conphar, Inc. | EGN | Class I | 1982-05-28 |
| K821273 | MAYO SCISSOR STRAIGHT 6 3/4 | Conphar, Inc. | EGM | Class II | 1982-05-28 |
| K821299 | CER-MATE | J. Aderer, Inc. | EJS | Class II | 1982-05-28 |
| K821358 | MODIFIED RONGEURS FOR SPINAL & ORTH. S. | Downs Surgical , Ltd. | EMH | Class I | 1982-05-28 |
| K821364 | PROFLEX FLEXIBLE SCALER | Teledyne Densco | EHM | Class I | 1982-05-28 |
| K821222 | GOLDSMITH & REVERE TENARY ALLOY | Goldsmith & Revere, Inc. | EJJ | Class II | 1982-05-24 |
| K821155 | DENTAL FLOSS HOLDER | Eric L. Smith | JES | Class I | 1982-05-24 |
| K821077 | CONPHAR | Conphar, Inc. | EGN | Class I | 1982-05-24 |
| K820979 | RESILIENT GUM EXERCISER | Martin A. Hass, D.D.S. | JET | Class I | 1982-05-10 |
| K821022 | PRECIOUS METAL ALLOYS | J. Aderer, Inc. | EJS | Class II | 1982-05-10 |
| K813638 | MULTI-UNIT, MULTI-PURPOSE DEVICE | The Scott & Fetzer Co. | EFS | Class I | 1982-05-07 |
| K820944 | DENTAL ARCH BAR | Unisplint Corp. | DYX | Class II | 1982-05-05 |
| K820907 | DENTISCOPE | Chayes Virginia, Inc. | EAY | Class I | 1982-05-05 |
12,679 clearances in the Dental panel. Data: openFDA.