Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 36
- Latest Decision
- 1994-03-31
Clearances · page 89 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K940845 | SYSTEM 1 | Sybron Dental Specialties, Inc. | DYH | Class II | 1994-03-31 |
| K933671 | ULTRACAM | Dental Vision Direct, Inc. | EIA | Class I | 1994-03-31 |
| K940929 | AURIUM 50Y | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-31 |
| K940856 | AURIUM G13 (HIGH GOLD CROWN AND BRIDGE ALLOY) | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-29 |
| K940789 | AURIUM C | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-29 |
| K940761 | AURIUM 22KT | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-28 |
| K940855 | AURIUM SG (HIGH GOLD CROWN AND BRIDGE ALLOY) | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-28 |
| K932893 | VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY | Vident | EJH | Class II | 1994-03-28 |
| K940779 | AURIUM D4 | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-28 |
| K940749 | LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10 | Aalba Dent, Inc. | EJH | Class II | 1994-03-28 |
| K940402 | SUPERGEL/SUPPRESSED DUST | Harry J. Bosworth Co. | ELW | Class II | 1994-03-28 |
| K940787 | AURIUM B4 | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-28 |
| K940788 | AURIUM 830 | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-28 |
| K933080 | ORTHOTECH DURA-GOLD BARCKETS | Orthotech | EJF | Class I | 1994-03-23 |
| K940747 | SILFREE 79 | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-22 |
| K940379 | EXTRUDE | Sybron Dental Specialties, Inc. | ELW | Class II | 1994-03-22 |
| K940719 | SILFREE | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-21 |
| K935616 | SALIVA EJECTOR DISPOSABLE | Asa Instruments S.R.L. | DYN | Class I | 1994-03-21 |
| K935758 | HYGOFLEX SALIVA-EJECTOR | J.H.Orsing AB | DYN | Class I | 1994-03-21 |
| K940617 | SUREFIRE 12 | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-21 |
| K940618 | AUROLITE 41 | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-21 |
| K940619 | SILFREE 79+ | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-21 |
| K931300 | FLASH DENT | Chicago X-Ray Systems, Inc. | EHD | Class II | 1994-03-21 |
| K934195 | VITA CELAY BLANKS AND VITA CELAY OPTIMIZER | Vident | EIH | Class II | 1994-03-18 |
| K940579 | AURIUM 239 | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-17 |
| K940580 | AUROLITE 6 | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-17 |
| K940485 | AUROLITE 2A | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-17 |
| K940610 | AUROLITE 9 | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-17 |
| K940680 | VERSADOWEL POST SYSTEM | Dental Power, Inc. | ELR | Class I | 1994-03-15 |
| K936222 | DENTIN CONDITIONING AND ADHESIVE SYSTEM | Jeneric/Pentron, Inc. | KLE | Class II | 1994-03-15 |
| K935535 | TYTIN | Kerr Corporation (Danbury) | EJJ | Class II | 1994-03-11 |
| K921805 | STRYKER PRECISION DENTAL IMPLANT SYSTEM | Stryker Instruments | DZE | Class II | 1994-03-10 |
| K925567 | E 4000 DENTAL OPERATING CHAIR | Dentalez Group | KLC | Class I | 1994-03-10 |
| K940410 | NEW GEAR RELEASABLE HEADGEAR | Ortho Kinetics Corp. | DZB | Class II | 1994-03-10 |
| K935961 | GC FUJI COAT LC | GC America, Inc. | KLE | Class II | 1994-03-10 |
| K940260 | THERMAL PULP TESTER | Union Broach, Div. Moyco Industries, Inc. | EAT | Class II | 1994-03-07 |
| K940165 | ALASTIK | Unitek Corp. | ECI | Class I | 1994-03-07 |
| K940435 | AUROLITE 54+2 | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-07 |
| K933462 | CONICAL ABUTMENT | Implant Innovations, Inc. | DZE | Class II | 1994-03-07 |
| K935735 | ATTACHMENT BOND | Heraeus Kulzer, Inc. | KLE | Class II | 1994-03-07 |
| K931772 | SURETIP SYRINGE TIP COVER | Western M/D, Inc. | ECB | Class I | 1994-03-07 |
| K932873 | SEAC MOBILE UNIT BY ASI MEDICAL | Asi Medical, Inc. | EIA | Class I | 1994-03-07 |
| K940434 | AUROLITE 2B | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-07 |
| K940361 | AUROLITE 1C | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-07 |
| K933193 | IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L | The Stern Metals Co., Inc. | DZE | Class II | 1994-03-07 |
| K926177 | DW246 #43 | Ivoclar North America, Inc. | EJT | Class II | 1994-03-07 |
| K940360 | AUROLITE 85 | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-04 |
| K915576 | HUBUKA HYG TOOTHBRUSH | Hukuba Dental Corp. | MMD | Class I | 1994-03-04 |
| K935960 | GC TEMPRON | GC America, Inc. | EBG | Class II | 1994-03-04 |
| K926154 | HANDPIECE MODELS: MS-350;RS-350;N-270 AIR-MOTOR | Dabi-Atlante America Corp. | EFB | Class I | 1994-03-04 |
| K940341 | AUROLITE 1K | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-04 |
| K940337 | SILFREE 2 HIGH-PALLADIUM ALLOY FOR PORCELAIN APPLICATION | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-04 |
| K926155 | CA AND ST | Dabi-Atlante America Corp. | EFB | Class I | 1994-03-04 |
| K940343 | AUROLITE 1B | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-04 |
| K940342 | SUREFIRE W | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-04 |
| K940282 | SUREFIRE 10 | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-04 |
| K940280 | SUREFIRE A | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-01 |
| K926305 | IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER | The Stern Metals Co., Inc. | DZE | Class II | 1994-03-01 |
| K925116 | ELECTROSURGICAL ELECTRODE | Premier | EKZ | Class II | 1994-03-01 |
| K940252 | FINESSE PORCELAIN SYSTEM | Dentsply Intl. | EIH | Class II | 1994-03-01 |
| K940281 | ARGEDENT 51SF | Argen Precious Metals, Inc. | EJT | Class II | 1994-03-01 |
| K940278 | AURIUM J | Argen Precious Metals, Inc. | EJT | Class II | 1994-02-28 |
| K922673 | FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING | Glasspan, Inc. | ELS | Class II | 1994-02-25 |
| K940120 | ALPHA-DENT | Wallace A. Erickson & Co. | ELW | Class II | 1994-02-25 |
| K923937 | HYDRO FLOSS | Hydro Floss, Inc. | EFS | Class I | 1994-02-25 |
| K933030 | PANAVIA 21 | Kuraray Co. | EMA | Class II | 1994-02-24 |
| K933612 | JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT) | Jedental Co., Inc. | EMA | Class II | 1994-02-24 |
| K930584 | MAGNACORE | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1994-02-22 |
| K930144 | THE SCITECH ONE-DAY FILTER | Scitech Solutions, Inc. | EIA | Class I | 1994-02-22 |
| K930583 | MEGABOND SYSTEM | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1994-02-22 |
| K934758 | R2+ | Jeneric/Pentron, Inc. | EJH | Class II | 1994-02-18 |
| K935046 | GX-770 X-RAY CONTROL, MODEL 46-404600G4 | Gendex Corp. | EHD | Class II | 1994-02-18 |
| K926070 | PRIMODENT ACRYLIC TEETH | I.T.C. Ent. | ELM | Class II | 1994-02-17 |
| K940111 | AURIUM 224 | Argen Precious Metals, Inc. | EJT | Class II | 1994-02-16 |
| K925889 | FORCEPS, DRESSING, DENTAL | Protector, Inc. | EKJ | Class I | 1994-02-15 |
| K925890 | MIRROR, MOUTH | Protector, Inc. | EKJ | Class I | 1994-02-15 |
| K925888 | EXPLORER, OPERATIVE | Protector, Inc. | EKJ | Class I | 1994-02-15 |
| K930155 | MINIBALL ABUTMENT | Steri-Oss, Inc. | DZE | Class II | 1994-02-14 |
| K934714 | ENDODONTIC PULP CANAL SPREADER | Excellence IN Endodontics, Inc. | ELC | Class II | 1994-02-14 |
| K924219 | ENDOSSEOUS IMPLANTS | The Stern Metals Co., Inc. | DZE | Class II | 1994-02-14 |
| K932298 | PRO'S NEO-LASTICS | Professional Positioners, Inc. | ECI | Class I | 1994-02-14 |
| K925776 | BRANEMARK SYSTEM INTERLOCKING ABUTMENT/GOLD CYLIND | Nobelpharma USA, Inc. | DZE | Class II | 1994-02-10 |
| K926205 | MONOSTERYL | Utensili Super Abrasivi | EJL | Class I | 1994-02-10 |
| K922732 | INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER | Interpore Intl. | DZE | Class II | 1994-02-10 |
| K936113 | INDIPERSE | Indisperse Distributing, Inc. | EJJ | Class II | 1994-02-10 |
| K922818 | SNORE-NO-MORE | Great Lakes Orthodontics, Ltd. | LQZ | Class II | 1994-02-09 |
| K931767 | ASTRA TECH IMPLANTS-DENTAL SYSTEM | Astra Tech, Inc. | DZE | Class II | 1994-02-08 |
| K935155 | MERSHON BAND PUSHER | Dentauraum, Inc. | ECS | Class I | 1994-02-04 |
| K934002 | PERIO/ENDO LENS | New Image Industries, Inc. | EIA | Class I | 1994-02-04 |
| K935139 | FASCINATION CERAMIC BRACKET | Dentauraum, Inc. | EJF | Class I | 1994-02-04 |
| K935140 | DENTAURUM STEEL LIGATURE WIRES | Dentauraum, Inc. | DZC | Class I | 1994-02-04 |
| K940030 | BISCO COMPOSITE | Bisco, Inc. | EMA | Class II | 1994-02-04 |
| K934757 | CU-FREE & LTA | Jeneric/Pentron, Inc. | EJS | Class II | 1994-02-04 |
| K935144 | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS | Dentauraum, Inc. | ECI | Class I | 1994-02-04 |
| K936070 | TREND SET 2 PLUS | Confi-Dental Products Co. | ELW | Class II | 1994-02-04 |
| K936100 | CLEARFIL LINER BOND 2 | Kuraray Intl. Corp. | KLE | Class II | 1994-02-03 |
| K935440 | JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED | Johnson & Johnson Consumer Products, Inc. | JES | Class I | 1994-02-03 |
| K932828 | CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE | Alpha-Dent | EBF | Class II | 1994-02-03 |
| K914137 | HA-BIONTEGRATED DENTAL IMPLANT SYSTEMS | Lifecore Biomedical, Inc. | DZE | Class II | 1994-02-03 |
| K926121 | BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI | Dentmed , Ltd. | EJI | Class II | 1994-02-03 |
12,679 clearances in the Dental panel. Data: openFDA.