meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
47
Latest Decision
1988-02-23

Clearances · page 109 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K875149 PERIDONTAL SCALING SOLUTION-B Dentsply Intl. EFS Class I 1988-02-23
K875132 PERIODONTAL SCALING SOLUTION-A Dentsply Intl. EFS Class I 1988-02-23
K874945 CEMENT LINER Dentsply Intl. EMA Class II 1988-02-19
K873926 STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT Storz Instrument Co. JEY Class II 1988-02-19
K874500 GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM. Harry J. Bosworth Co. EMA Class II 1988-02-18
K874805 TATUNG'S DENTURE CLEANING SOLUTION Tatung Company of America, Inc. EFT Class I 1988-02-16
K874189 DUAL-CURE RADIOPAQUE Pentron Corp. EBF Class II 1988-02-11
K874821 LUNAR CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL Deringer-Ney, Inc. EJS Class II 1988-02-08
K874944 MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT Dentsply Intl. EBC Class II 1988-02-08
K874471 SUPER FLOSSER U.S. Pacific Corp. JES Class I 1988-01-28
K874556 BISCO PIT AND FISSURE SEALANT Bisco, Inc. EBC Class II 1988-01-28
K874557 BISCO PORCELAIN REPAIR KIT Bisco, Inc. EBC Class II 1988-01-28
K874964 DENTAL HAND INSTRUMENTS Solway, Inc. EKJ Class I 1988-01-27
K873123 LEE COMPOSITE INLAY SYSTEM Lee Pharmaceuticals EBF Class II 1988-01-20
K873317 EZ BRUSH & FLOSS Ez Products, Ltd. EFW Class I 1988-01-19
K874374 THE WOOG ORATEST Woog Intl. EAZ Class I 1988-01-19
K874275 OPTEC SUPPLEMENTARY KIT Pentron Corp. EBF Class II 1988-01-19
K874543 MODEL OPO-32 IRRIGATION SLEEVE Allergan, Inc. EIB Class I 1988-01-14
K874162 OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT Pentron Corp. EBF Class II 1988-01-12
K874335 EXPLORER-DENTAL PROBER Military Engineering, Inc. EKJ Class I 1987-12-29
K874294 AUTOCHUCK ATTACHMENT Den-Tal-Ez Mfg Co., Inc. EFB Class I 1987-12-29
K874226 STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET Advanced Orthodontics Systems, Inc. EJF Class I 1987-12-29
K874074 TEMPORARY DISCLOSING SOLUTION Dentsply Intl. KLE Class II 1987-12-29
K874227 PLASTIC BRACKETS Advanced Orthodontics Systems, Inc. DYW Class II 1987-12-29
K873356 INSURE PORCELAIN VENEER BONDING SYSTEM Cosmedent, Inc. EMA Class II 1987-12-29
K874025 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN Astron Dental Corp. EBI Class II 1987-12-23
K874194 PROTECT DROPS/SAME AS K874070 John O. Butler EJK Class II 1987-12-16
K873763 BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITE Geistlich-Pharma LYC Class II 1987-12-08
K874238 MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY Belmont Equipment Corp. EHD Class II 1987-12-07
K872810 STRUNG DENTAL ROLLS American Silk Sutures, Inc. EFN Class I 1987-12-04
K873960 LEWIS SAFE SLEEVE Cheri Lewis, D.D.S. EIF Class I 1987-12-04
K873698 STERILIZED DENTAL BIT PACKAGING Florida Diamond Instruments Corp. EJL Class I 1987-12-03
K874535 MICROTEK MINI-MAX DRILL SYSTEM Microtek Medical, Inc. DZI Class II 1987-11-23
K872959 CLEARFIL PHOTO BOND Kuraray Co. KLE Class II 1987-11-20
K873545 PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT Commercial Products & Engineering Co. EHZ Class I 1987-11-20
K873738 ACRYLIC BASE DENTURE MATERIALS E&D Dental Manufacturing Co. EBI Class II 1987-11-20
K873661 CHROME-COBALT BASE DENTAL ALLOY North American Alloys, Inc. EJH Class II 1987-11-16
K873683 CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) Pentron Corp. EBF Class II 1987-11-16
K872039 MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS Life-Tech Intl., Inc. EAT Class II 1987-11-13
K873886 CLEARFIL PORCELAIN REPAIR SYSTEM Kuraray Co. EBF Class II 1987-11-12
K873686 DIAMOND-LUSTER DENTAL POLISHING PASTE Scientific Pharmaceuticals, Inc. EJR Class I 1987-11-12
K874401 TITANIUM SUCTION TIP Implant Innovations International, Inc. EHZ Class I 1987-11-12
K864294 HENKE-JECT PRESSURE SYRINGE (MODIFICATION) Smith & Nephew, Inc. EGM Class II 1987-11-04
K873644 PULP PEN The Hygenic Corp. EAT Class II 1987-10-27
K873878 #24L SYSTEM Pentron Corp. EBF Class II 1987-10-27
K873146 USI BASIC. AG 1050. AG 1090 Cranston Ind., Inc. ELC Class II 1987-10-27
K873373 SINTERLOY Denpac Corp. EJS Class II 1987-10-27
K873671 COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM Coltene, Inc. EKS Class I 1987-10-27
K873147 USI DENTAL POLISHER. A/G-20 Cranston Ind., Inc. EFA Class I 1987-10-14
K872622 ORTHODONTIC ARCH Wonder Wire EJZ Class I 1987-10-09
K873649 FLEX GOLD Flexmedics EJF Class I 1987-10-05
K873153 CAULK'S VPS CARTRIDGE SYSTEM Dentsply Intl. EID Class I 1987-09-16
K873069 MODIFIED VISIO-SEAL Espe GmbH (Us) EBC Class II 1987-09-15
K873143 ROS-TR SYSTEM Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn DZE Class II 1987-09-11
K872444 SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL 3M Company EBF Class II 1987-09-11
K872471 TITANE SL DENTAL BURR Titane SL Co. ECM Class I 1987-09-11
K871785 DENTURE CLEANSING TABLET Pennex Products Co., Inc. EFT Class I 1987-09-11
K872147 KERR CAVALITE Kerr Corporation (Danbury) EJK Class II 1987-08-26
K873209 PLAQUE-SWEEP Dentsply Intl. EFB Class I 1987-08-25
K871773 BIO-OSS PURE NAT HYDROXYAPATITE ENDOSS IMPLANT Geistlich-Pharma LYC Class II 1987-08-24
K872510 DEN-MAT TENURE Den-Mat Corp. EBF Class II 1987-08-24
K873002 MIN-IDENTOFLEX Centrix, Inc. EHJ Class I 1987-08-17
K872089 APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G) Asahi Optical Co. C/O Rosati Associates, P.C. DZE Class II 1987-08-14
K872960 CLEARFIL POSTERIOR NEW BOND Kuraray Co. EBF Class II 1987-08-11
K872521 DENTURE CLEANSERS Dental Research Laboratories JER Class I 1987-08-11
K872943 DISPOSABLE ARTICULATOR Dentsply Intl. EJP Class I 1987-08-11
K871849 LIGHT CURE DENTURE GLAZE Austenal Dental, Inc. EBI Class II 1987-08-10
K872907 DENTIN ADHESIVE Dentsply Intl. EBF Class II 1987-08-03
K871816 STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM Stryker Corp. EAY Class I 1987-08-03
K872890 SYNERGY Scientific Pharmaceuticals, Inc. EBF Class II 1987-08-03
K872098 CREMEEN ALVEOLAR BONE CALIPER Bowen & Company, Inc. EIL Class I 1987-07-31
K871834 DRILL, HAND, BONE, SMEDBERG Military Engineering, Inc. DZJ Class II 1987-07-31
K871929 PROBRIGHT TOOTH POLISHER Lap Investments, Inc. JEQ Class I 1987-07-31
K872091 CURRETTES, ALVEOLAR (MOLT AND MILLER) Military Engineering, Inc. EMS Class I 1987-07-31
K871955 TEMPORARY SCREW Implant Innovations International, Inc. DZE Class II 1987-07-31
K871953 TEMPORARY BRIDGE HEAD Implant Innovations International, Inc. DZE Class II 1987-07-31
K871887 ANCHOR IIA/2 STAGE OSSEO. TIT. 6/4 ALLOY IMPLANT Anchor Implants , Ltd. DZE Class II 1987-07-31
K871954 ABUTMENT HEAD POST Implant Innovations International, Inc. DZE Class II 1987-07-31
K871879 SOFSWAB Plastic Engineered Products Co. EFW Class I 1987-07-28
K872569 TEMREX ETCHING GEL Scientific Pharmaceuticals, Inc. EBF Class II 1987-07-21
K872745 VINYL POLYSILOXANE IMPRESSION SYSTEM Crown Delta Corp. ELW Class II 1987-07-21
K871898 IMPERVA-P Shofu Dental Corp. EBF Class II 1987-07-21
K872746 VITALLIUM WIRE Austenal Dental, Inc. EJW Class I 1987-07-21
K871899 IMPERVA-A Shofu Dental Corp. EBF Class II 1987-07-21
K871637 CLEARFIL CORE NEW BOND Kuraray Co. EBF Class II 1987-07-17
K870041 FLEXIBLE FASCICULATED BONE PLATE The Deca Co. JEY Class II 1987-07-17
K871634 CLEARFIL FII NEW BOND Kuraray Co. EBF Class II 1987-07-17
K871635 CLEARFIL POSTERIOR 3 Kuraray Co. EBF Class II 1987-07-16
K872240 PORTABLE DENTAL X-RAY UNIT MODEL 4000 Home/Office Dental, Inc. EHD Class II 1987-07-16
K872215 PERIO-TEST Dr. Bernard Loewenthal EIL Class I 1987-07-10
K871863 ADBUTMENT CYLINDER AND SCREW Implant Innovations International, Inc. DZE Class II 1987-07-10
K871862 POST. SCREW & HEX DRIVER/ADBUT & ADBUT HEAD DRIVER Implant Innovations International, Inc. DZE Class II 1987-07-10
K872243 PEKALUX(TM) Columbus Dental Mfg. Co. EBF Class II 1987-07-07
K871406 THE WOOG ORABRUSH Woog Intl. JEQ Class I 1987-07-07
K872279 SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER 3M Company EBF Class II 1987-07-02
K871164 GLUMA(TM) BONDING SYSTEM Columbus Dental Mfg. Co. EBF Class II 1987-07-02
K872251 ABRASIVE DISC - POLISHING WHEEL Dentsply Intl. EJR Class I 1987-07-02
K872272 PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS Columbus Dental Mfg. Co. EBF Class II 1987-07-02
K871636 CLEARFIL PORCELAIN BOND Kuraray Co. KLE Class II 1987-07-02
K871818 SPATULA, DENTAL, CEMENT Military Engineering, Inc. EJB Class I 1987-07-02

12,679 clearances in the Dental panel. Data: openFDA.