meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
36
Latest Decision
1989-12-04

Clearances · page 104 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K895958 BREVET FLOSS PICK (AUTOCLAVE STERILIZER) Brevet, Inc. EKJ Class I 1989-12-04
K892412 POLYETHER-RETARDER Espe GmbH (Us) ELW Class II 1989-12-04
K892453 KULZER GLAS-IONOMER CEMENT Kulzer, Inc. EMA Class II 1989-12-04
K896131 GNATHOMAT ARTICULATOR Ivoclar North America, Inc. EJP Class I 1989-12-04
K895333 OSSEODENT PROSTHETIC KIT Celtrix Laboratories DZE Class II 1989-11-29
K893794 APEXIT ROOT CANAL SEALER Williams Dental Co., Inc. KIF Class II 1989-11-29
K895959 BREVET FLOSS PICK (COLD STERILIZATION FLUIDS) Brevet, Inc. EKJ Class I 1989-11-29
K894061 STUDIO UNO Eurodent, Inc. EIA Class I 1989-11-21
K895164 EAGLE DS American Sterilizer Co. ECG Class I 1989-11-17
K895467 ORTHOPHOS AND ORTHOPHOS C Siemens Medical Solutions USA, Inc. EHD Class II 1989-11-17
K891338 SMYLON (DENTAL STAIN ERASER) The Smylon Co. MAU Class I 1989-11-14
K895561 PEMACO 3000 INTRAORAL DENTAL WAX Pemaco, Inc. EGD Class I 1989-11-06
K895564 PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD Pemaco, Inc. EGD Class I 1989-11-06
K895566 PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT Pemaco, Inc. EGD Class I 1989-11-06
K895563 PEMACO BITE WAX SHEETS Pemaco, Inc. EGD Class I 1989-11-06
K895562 PEMACO 2000 INTRAORAL DENTAL WAX Pemaco, Inc. EGD Class I 1989-11-06
K895259 PIK POCKET(R), MODEL PP-3 Teledyne Water Pik EFS Class I 1989-11-01
K894315 RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT Lee Pharmaceuticals KLE Class II 1989-10-31
K894896 ANSWER DENTAL IMPLEMENT, EXPLORER Tern Chien Ent. Co., Ltd. EKJ Class I 1989-10-30
K894924 990 GOLD Comprehensive Holistic Dentistry EJT Class II 1989-10-30
K894895 ANSWER DENTAL IMPLEMENTS, MIRROR Tern Chien Ent. Co., Ltd. EKJ Class I 1989-10-30
K894897 ANSWER DENTAL IMPLEMENT, FORCEPS Tern Chien Ent. Co., Ltd. EKJ Class I 1989-10-30
K895163 FORCE II American Orthodontics DYH Class II 1989-10-27
K892839 PALGARAPID Espe GmbH (Us) ELW Class II 1989-10-27
K894890 CRYSTALLINE C2 AND CRYSTALLINE L3 Confi-Dental Products Co. EBF Class II 1989-10-27
K895565 PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD Pemaco, Inc. EGD Class I 1989-10-24
K892710 ARISTEE (TEMPORARY CROWN & BRIDGE RESIN) Prometex, Inc. EBG Class II 1989-10-24
K895222 CURAY-FORM Scientific Pharmaceuticals, Inc. EBI Class II 1989-10-24
K883418 DE-BOND 200 Scheu-Dental EKS Class I 1989-10-24
K894994 DENTIN BONDING SYSTEM Cosmedent, Inc. KLE Class II 1989-10-24
K894644 CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST Jeneric/Pentron, Inc. EBF Class II 1989-10-20
K894639 SKYROCK AND LIGHT SUPERBOND Dent Zar, Inc. DYH Class II 1989-10-20
K892124 IMPLA-MED IMPLANT SYSTEM Impla-Med DZE Class II 1989-10-20
K895986 PRECISION DENTAL ATTACHMENTS Implant Support Systems, Inc. EGG Class I 1989-10-18
K894564 RELIANCE LIGHT CURE RETAINER ACRYLIC Reliance Orthodontic Products, Inc. EBI Class II 1989-10-17
K891331 UNI-STICK PLASTIC LIGATURES American Orthodontics EJF Class I 1989-10-16
K894565 LIGHT BOND SEALANT WITH FLUORIDE Reliance Orthodontic Products, Inc. DYH Class II 1989-10-13
K894373 NIPRO DENTAL NEEDLE Pharma-Plast USA, Inc. DZM Class I 1989-10-13
K894759 ALLPAC(TM) MATERIAL Barrier Concepts, Inc. EIA Class I 1989-10-13
K894606 MICRO-AIRE HIGH SPEED DRILL (2910-000) Micro-Aire Surgical Instruments, Inc. EFB Class I 1989-10-13
K894933 PERLIDENT Germiphene Corp. EJR Class I 1989-10-12
K893482 KORN MANDIBULAR ADVANCER American Orthodontics EJF Class I 1989-10-12
K891613 OVERDENTURE ATTACHMENT Implant Innovations International, Inc. DZE Class II 1989-10-10
K894247 PERIODONTAL IRRIGATING SOLUTION-D Dentsply Intl. ELC Class II 1989-10-06
K894331 OSSEODENT SURGICAL KIT Collagen Corp. DZE Class II 1989-10-04
K894160 HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL Artech Corp. DZE Class II 1989-09-28
K894150 COUNTERBORE FOR SS SUBMERGED SCREW PLANT Artech Corp. DZJ Class II 1989-09-27
K894151 IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT Artech Corp. DZJ Class II 1989-09-27
K894281 FIRST IMPRESSION WITH CHLORHEXIDINE Coe Laboratories, Inc. ELW Class II 1989-09-26
K894566 MAXIMUM CURE SEALANT WITH FLUORIDE Reliance Orthodontic Products, Inc. DYH Class II 1989-09-19
K894391 PVS DUAL CURE VENEER BONDING KIT Jelenko Co. KLE Class II 1989-09-19
K894219 TEMP BOND NE Kerr Corporation (Danbury) EMA Class II 1989-09-18
K894358 LUMINA ORTHODONTIC BRACKET Ormco Corp. EJF Class I 1989-09-15
K894781 OPTIFLEX Ormco Corp. EJF Class I 1989-09-15
K892861 DENTAL PIK U.S. Dentek Corp. EKS Class I 1989-09-15
K894060 ESSE QUATTRO/ESSE UNO Eurodent, Inc. KLC Class I 1989-09-07
K894059 ISOLIGHT Eurodent, Inc. EAZ Class I 1989-09-07
K885133 APACERAM ARTIFICIAL DENTAL IMPLANT Asahi Optical Co. C/O Rosati Associates, P.C. DZE Class II 1989-09-05
K891173 OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-60 Ceramed Corp. LYC Class II 1989-09-01
K883717 BIO-VENT Core-Vent Corp. DZE Class II 1989-09-01
K894015 WATER PIK(R) Teledyne Water Pik EFS Class I 1989-08-28
K893655 KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK American Orthodontics EJF Class I 1989-08-23
K893688 HIGH NOBLE, TYPE III DENTAL CASTING ALLOY Jelenko Co. EJT Class II 1989-08-23
K892517 TULUX-FILTER Espe GmbH (Us) EBZ Class II 1989-08-21
K894120 MADEGOM LTDA. DENTAL DAM Madegom EIE Class I 1989-08-21
K893889 FD3500 (DENTAL CHAIR) Oriola OY Finndent KLC Class I 1989-08-15
K893943 FD 200 DENTAL STOOL Oriola OY Finndent KLC Class I 1989-08-15
K893944 FD 300 DENTAL STOOL Oriola OY Finndent KLC Class I 1989-08-15
K893890 FD4500 (DENTAL CHAIR) Oriola OY Finndent KLC Class I 1989-08-15
K893844 3D DENTAL DIAMOND ROTARY INSTRUMENTS Lustgarten Multi-Tech International, Inc. DZP Class I 1989-08-11
K893945 FD 350 DENTAL STOOL Oriola OY Finndent KLC Class I 1989-08-11
K891607 DENTANURSE The Irish Scene EMA Class II 1989-08-11
K893946 FD 400 DENTAL STOOL Oriola OY Finndent KLC Class I 1989-08-08
K893219 MATRX DENTAL UNIT Matrix Medica, Inc. EIA Class I 1989-08-07
K884296 O BUTMENT O Co., Inc. DZE Class II 1989-08-01
K883804 E-MITT (CONDUCTIVE HAND COVER) The Institute For Technology Development EAT Class II 1989-07-31
K890449 PERMAGUM PUTTY SOFT & PERMAGUM GARRANT Wacker-Chemie GmbH ELW Class II 1989-07-27
K893454 CHAIR/STOOL UNIT DENTAL OPER., PORTABLE, FIELD Atlantic Industries, Inc. KLC Class I 1989-07-25
K881133 70-X/RVG (RADIOVISIOGRAPHY) Trophy Radiologie EHO Class I 1989-07-20
K893484 MULTIPHASE ORTHODONTIC WIRE American Orthodontics EJF Class I 1989-07-14
K893045 A-DEC PRIORITY 1005 CHAIR A-Dec, Inc. KLC Class I 1989-07-14
K893555 X-RING AND SPEED STIX PLASTIC LIGATURES American Orthodontics EJF Class I 1989-07-14
K892935 RESOUND IMPRESSION MATERIAL Resound Corp. ELW Class II 1989-07-14
K890713 OVERDENTURE - STUD ATTACHMENT Austenal Dental, Inc. DZE Class II 1989-07-14
K892806 TUF-COAT G-C Intl. Corp. ELL Class II 1989-07-14
K891982 J1 ATTACHMENT (ORTHODONTIC APPLIANCE) T.M.K. Dental Products EJF Class I 1989-07-14
K893044 A-DEC DENTAL LIGHT A-Dec, Inc. EAZ Class I 1989-07-14
K893566 ARGENCO 50 TYPE IV TYPE IV DENTAL GOLD ALLOY Argen Precious Metals, Inc. EJT Class II 1989-07-14
K893550 PLASTIC FORCE MODULE American Orthodontics EJF Class I 1989-07-14
K893481 CRYSTAR(TM) ANTI-GREENING LIQUID Shofu Dental Corp. ELL Class II 1989-07-14
K893483 BONDABLE RETAINER AND SPACE MAINTAINER American Orthodontics EJF Class I 1989-07-14
K893396 AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM American Orthodontics DYH Class II 1989-06-23
K892882 DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 Nieusma R & D, Inc. EHZ Class I 1989-06-23
K892881 DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 Nieusma R & D, Inc. EHZ Class I 1989-06-23
K893549 X-RING SEPARATORS American Orthodontics EJF Class I 1989-06-23
K893686 ARGELOY N.P. Argen Precious Metals, Inc. EJT Class II 1989-06-23
K885115 IMD 7GX Medical Dental Technology Co. EFB Class I 1989-06-23
K893565 ARGENCO 68 TYPE IV DENTAL GOLD ALLOY Argen Precious Metals, Inc. EJT Class II 1989-06-23
K893654 MEMORY CHAIN American Orthodontics EJF Class I 1989-06-23
K893542 DIASTEMA CLOSING KIT American Orthodontics EJF Class I 1989-06-23

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