Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 40
- Latest Decision
- 1993-05-22
Clearances · page 93 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K925088 | EXPANSION SCREWS | Forestadent | DYJ | Class I | 1993-05-22 |
| K931169 | MDT DENTAL CHAIR | Mdt Corp., Inc. | KLC | Class I | 1993-05-20 |
| K920533 | DENTIN BONDING AGENT | Confi-Dental Products Co. | EBF | Class II | 1993-05-19 |
| K912724 | GUIDOR(TM) | Procordia Oratech AB | NPK | Class II | 1993-05-13 |
| K924155 | SURA SNAP | Metalor Dental USA Corp. | DZE | Class II | 1993-05-12 |
| K930869 | ECO TOOTHBRUSH | Recycla-Dent, Inc. | EFW | Class I | 1993-05-06 |
| K926033 | VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD | Harry J. Bosworth Co. | ELW | Class II | 1993-05-05 |
| K923405 | THE HERBST APPLIANCE | Ormco Corp. | EJF | Class I | 1993-05-05 |
| K926145 | NUGOLD 2% | Jeneric/Pentron, Inc. | EJS | Class II | 1993-05-05 |
| K924287 | 710 POROUS HA PARTICLES-BII-PORE | Bio-Interfaces, Inc. | LYC | Class II | 1993-04-30 |
| K924140 | TUFF TIES | Glenroe Technologies | ECI | Class I | 1993-04-27 |
| K930338 | ORTHOCEPH OC100 | Instrumentarium Corp. | EHD | Class II | 1993-04-27 |
| K926556 | VIVALUX | Ivoclar North America, Inc. | EBF | Class II | 1993-04-23 |
| K930086 | ORTHOLUX XT | 3M Company | EBZ | Class II | 1993-04-23 |
| K925779 | BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS | Nobelpharma USA, Inc. | NHA | Class II | 1993-04-20 |
| K930989 | PULPDENT UNFILLED DUAL CURE BONDING RESIN | Pulpdent Corp. | KLE | Class II | 1993-04-20 |
| K926247 | OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005 | Omron Healthcare, Inc. | JEQ | Class I | 1993-04-14 |
| K926246 | OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142 | Omron Healthcare, Inc. | JEQ | Class I | 1993-04-14 |
| K925771 | BRANEMARK SYSTEM TITANIUM COVER SCREWS | Nobelpharma USA, Inc. | DZE | Class II | 1993-04-14 |
| K925769 | BRANEMARK SYSTEM ABUTMENTS COMPLETE | Nobelpharma USA, Inc. | NHA | Class II | 1993-04-14 |
| K925777 | BRANEMARK SYSTEM ESTHETICONE ABUTMENT COMPLETE | Nobelpharma USA, Inc. | DZE | Class II | 1993-04-14 |
| K924288 | B1018 POROUS HA BII-PORE | Bio-Interfaces, Inc. | LYC | Class II | 1993-04-14 |
| K922487 | BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-PORE | Bio-Interfaces, Inc. | LYC | Class II | 1993-04-14 |
| K925778 | BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES | Nobelpharma USA, Inc. | DZE | Class II | 1993-04-14 |
| K924286 | 4060 POROUS HA PARTICULES BII PORE | Bio-Interfaces, Inc. | LYC | Class II | 1993-04-14 |
| K925773 | BRANEMARK SYSTEM GOLD CYLINDERS AND SCREWS | Nobelpharma USA, Inc. | DZE | Class II | 1993-04-14 |
| K925780 | BRANEMARK SYSTEM HEALING CAPS | Nobelpharma USA, Inc. | DZE | Class II | 1993-04-14 |
| K923473 | MULTIPURPOSE RESIN CEMENT | Dentsply Intl. | EMA | Class II | 1993-04-12 |
| K920843 | TOOTH CONDITIONER | Confi-Dental Products Co. | KZP | Class II | 1993-04-08 |
| K926492 | ARGION DENTAL CEMENT | Voco GmbH | EMA | Class II | 1993-04-08 |
| K923419 | TISMESH SYSTEM | Ti-Mesh, Inc. | JEY | Class II | 1993-04-08 |
| K915653 | KERAMAIL | Wilde-USA, Inc. | EIH | Class II | 1993-04-08 |
| K924139 | GLENROE ORTHO SEPS | Glenroe Technologies | ECI | Class I | 1993-04-08 |
| K930455 | CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER | Voco GmbH | EMA | Class II | 1993-04-08 |
| K923876 | RISKONTROL SINGLE USE | Riskontrol | ECB | Class I | 1993-04-05 |
| K926418 | CLIP | Voco GmbH | EBF | Class II | 1993-03-31 |
| K930601 | FREEDOM | J.F. Jelenko & Co., Inc. | EJT | Class II | 1993-03-31 |
| K924805 | ORTHODONTIC ARCH WIRE | Ultimate Wireforms, Inc. | DZC | Class I | 1993-03-31 |
| K926406 | DUAL CURE RELINE MATERIAL | Dentsply Intl. | EBI | Class II | 1993-03-31 |
| K925973 | VS1 GPF, VACU PF | Metalor Dental USA Corp. | EJT | Class II | 1993-03-31 |
| K930762 | SUPERSTAR | Jelenko Co. | EJT | Class II | 1993-03-31 |
| K925974 | CASTING GOLD,CERAMIC,GOLD WIRE,ALLOY PRECISION ATT | Metalor Dental USA Corp. | EJT | Class II | 1993-03-31 |
| K913404 | IMPLANDRILL - THREADED DENTAL IMPLANT | Impladrill , Ltd. | DZE | Class II | 1993-03-31 |
| K930481 | DENTAL CASTING ALLOY MODIFICATION-PF-4 | Deringer-Ney, Inc. | EJT | Class II | 1993-03-31 |
| K922984 | ORTHODONTIC BITE | American Orthodontics | LRK | Class II | 1993-03-31 |
| K924089 | OPTI-SHIELD | Fuji Optical Systems, Inc. | EFB | Class I | 1993-03-31 |
| K924378 | RESTOBOND 4 | Lee Pharmaceuticals | KLE | Class II | 1993-03-31 |
| K924211 | EJECTOR | Glenroe Technologies | DYN | Class I | 1993-03-31 |
| K926419 | CALCICUR | Voco GmbH | EJK | Class II | 1993-03-31 |
| K926238 | BISCO PORCELAIN ETCHING GEL | Bisco, Inc. | EIH | Class II | 1993-03-31 |
| K930482 | DENTAL CASTING ALLOY, MODIFICATION - PF-3 | Deringer-Ney, Inc. | EJT | Class II | 1993-03-31 |
| K923440 | APEX DIRECT BONDED BRACKETS | Apex Orthodontics, Inc. | EJF | Class I | 1993-03-31 |
| K923837 | DIMPLED MULTI MODULUS ARCH WIRE | Ultimate Wireforms, Inc. | DZC | Class I | 1993-03-31 |
| K926458 | BIFIX DENTAL CEMENT | Voco GmbH | EMA | Class II | 1993-03-31 |
| K926578 | UNI-STICK PLASTIC LIGATURE, MODIFIED | American Orthodontics | ECI | Class I | 1993-03-31 |
| K925062 | PERMAFLEX PERMANENT SOFT DENTURE RELINER | Protech Professional Products, Inc. | EBI | Class II | 1993-03-31 |
| K926575 | MAMMOTEST PRODUCT, MODIFICATION | Fischer Imaging Corp. | EHD | Class II | 1993-03-30 |
| K923360 | PORT-XD | Mobile Dental Equipment Corp. | EHD | Class II | 1993-03-30 |
| K925370 | TRIANGULAR JAW MICROLARYNGEAL FORCEPS | Pilling Co. | ELW | Class II | 1993-03-18 |
| K924823 | MICRODOSE SILANE | Unicep | ELL | Class II | 1993-03-16 |
| K923717 | JELENKO PORCELAIN SYSTEM PVS PROCELAIN | J.F. Jelenko & Co., Inc. | EIH | Class II | 1993-03-16 |
| K925579 | VERASOFT CASTING ALLOY | Aalba Dent, Inc. | EJH | Class II | 1993-03-16 |
| K926074 | PULPDENT DENTAL BOND ENCHANCER | Pulpdent Corp. | EBF | Class II | 1993-03-16 |
| K923757 | DENTAL DIAMOND DRILLS | Alpha Industrializacao DE Metais Ltda. | DZP | Class I | 1993-03-16 |
| K924824 | MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE | Unicep | EBC | Class II | 1993-03-16 |
| K924821 | MICRODOSE PORCELAIN ETCHANT | Unicep | ELL | Class II | 1993-03-16 |
| K925162 | MICRODOSE DENTIN CONDITIONER | Unicep | EBF | Class II | 1993-03-16 |
| K923714 | SYMPHONY | J.F. Jelenko & Co., Inc. | EJT | Class II | 1993-03-16 |
| K922100 | DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE | Graham Medical Products | EJJ | Class II | 1993-03-15 |
| K923817 | ULTRAGOLD | J.F. Jelenko & Co., Inc. | EJT | Class II | 1993-03-11 |
| K923718 | HP-3 | J.F. Jelenko & Co., Inc. | EJT | Class II | 1993-03-05 |
| K923716 | JEL-0-75 | J.F. Jelenko & Co., Inc. | EJT | Class II | 1993-03-05 |
| K924827 | MICRODOSE POTASSIUM OXYLATE | Unicep | LBH | Class II | 1993-03-05 |
| K923719 | SUNCAST D-KF | J.F. Jelenko & Co., Inc. | EJT | Class II | 1993-03-05 |
| K923715 | SUNCAST-D | J.F. Jelenko & Co., Inc. | EJT | Class II | 1993-03-05 |
| K924825 | MICRODOSE RC-EZ | Unicep | EKM | Class I | 1993-03-05 |
| K924822 | MICRODOSE ENAMEL ETCHANT | Unicep | EBF | Class II | 1993-03-05 |
| K924826 | MICRODOSE TOTAL ETCHANT | Unicep | EBF | Class II | 1993-03-05 |
| K923720 | SUNCAST | J.F. Jelenko & Co., Inc. | EJT | Class II | 1993-03-05 |
| K923232 | ENDODONTIC POST W/ ACCESSORIES | Veillette Ent. | ELR | Class I | 1993-03-05 |
| K923722 | HN-40 | J.F. Jelenko & Co., Inc. | EJT | Class II | 1993-03-05 |
| K923721 | PROSPECTOR | J.F. Jelenko & Co., Inc. | EJT | Class II | 1993-03-05 |
| K924292 | CERAPALL 6 -- MODIFIED | Metalor Dental USA Corp. | EJS | Class II | 1993-03-01 |
| K923713 | MICROSTAR | J.F. Jelenko & Co., Inc. | EJT | Class II | 1993-02-26 |
| K913581 | WILDE ADHESIVE BONDING SYSTEM | Wilde-USA, Inc. | KLE | Class II | 1993-02-26 |
| K922958 | KB58-KF | Jeneric/Pentron, Inc. | EJS | Class II | 1993-02-26 |
| K925713 | VITA CEREC DUO CEMENT | Vident | EMA | Class II | 1993-02-17 |
| K924138 | OSTEOMED M3 SYSTEM (SBF SYSTEM) | Osteomed Corp. | JEY | Class II | 1993-02-17 |
| K925829 | WAGGONER DENTAL MANUFACTURING STERIWATER SYSTEM | Waggoner Dental Mfg. | EIA | Class I | 1993-02-12 |
| K923640 | GK DENTAL AMALGAM ALLOY | The Patron Trading Corp. | EJJ | Class II | 1993-02-12 |
| K923709 | MEMORY WIRE | Wire Products | EJF | Class I | 1993-02-02 |
| K925408 | ORAL-B DENTAL TAPE WITH FLUORIDE | Oral-B Laboratories | JES | Class I | 1993-01-28 |
| K925383 | PHOTO CLEARFIL OPAQUER | Kuraray Co. | EBF | Class II | 1993-01-28 |
| K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | Oral-B Laboratories | JES | Class I | 1993-01-28 |
| K922779 | IMPLANT-PROPHY & PLASTIC DENTAL INSTRUMENT SYSTEM | Advanced Implant Technologies, Inc. | DZE | Class II | 1993-01-28 |
| K923307 | HEALTHPAK X-RAY SOX BARRIERS | Healthpak, Inc. | EAP | Class II | 1993-01-21 |
| K914257 | DENTURE PRODUCT X | Essential Dental Systems, Inc. | EFT | Class I | 1993-01-13 |
| K920909 | HEXLOCK SCREW | Imtec Corp. | DZE | Class II | 1993-01-12 |
| K925259 | CFR MONOGRAPH | Combe, Inc. | EFT | Class I | 1993-01-11 |
| K925275 | SOFT DENTURE RELINE MATERIAL ELASTOLINE | Great Lakes Orthodontics, Ltd. | EBI | Class II | 1993-01-11 |
12,679 clearances in the Dental panel. Data: openFDA.