meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
36
Latest Decision
1991-10-21

Clearances · page 97 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K914073 F21(R) DENTAL CEMENT Voco GmbH EMA Class II 1991-10-21
K911655 IMPLARETTE Implant Innovations International, Inc. EKJ Class I 1991-10-21
K913655 PROBASE HOT AND PROBASE COLD Ivoclar North America, Inc. EBI Class II 1991-10-17
K913836 VLC GLASS IONOMER Dentsply Intl. EMA Class II 1991-10-17
K913572 AUTOPACK NON-EUGENOL PERIODONTAL DRESSING Specialites Septodont EMA Class II 1991-10-09
K913947 IMPERVA BOND Shofu Dental Corp. EBF Class II 1991-10-09
K911285 PULPDENT POLYAMIDE DENTIN LINER Pulpdent Corp. EME Class I 1991-10-09
K913535 A-DEC DECADE 1020 CHAIR A-Dec, Inc. KLC Class I 1991-10-09
K913698 ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL Heraeus Kulzer, Inc. EBI Class II 1991-10-09
K913699 MODERN MATERIALS ORTHODONTIC RESIN Heraeus Kulzer, Inc. EBI Class II 1991-10-09
K913059 A-DEC KNEEBREAK 1030 CHAIR A-Dec, Inc. KLC Class I 1991-10-08
K911231 ORTHODONTIC WIRE Masel Industries, Inc. EJF Class I 1991-10-08
K913040 RIBBOND(TM) Ribbond, Inc. EBI Class II 1991-10-07
K910585 TSIR ANGLED ABUTMENTS Core-Vent Corp. DZE Class II 1991-10-04
K913537 MEMOSIL C.D. Heraeus Kulzer, Inc. ELW Class II 1991-10-04
K913099 PALFIQUE LITEPOSTERIOR Tokuyama America, Inc. EBF Class II 1991-10-02
K913068 DW238 #228-34A Ivoclar North America, Inc. EJS Class II 1991-10-02
K913069 DW238 #228-04B Ivoclar North America, Inc. EJS Class II 1991-10-02
K913019 PDI PARALLEL SIDED POST KIT Precident Corp. ELR Class I 1991-10-02
K913100 PALFIQUE INLAY Tokuyama America, Inc. EBF Class II 1991-10-02
K913030 MAX-I-PROBE IRRIGATION SYSTEM Smith & Nephew, Inc. EFS Class I 1991-09-30
K912430 DENTAL FLOSS Westone Products , Ltd. JES Class I 1991-09-30
K913574 SEPTOCAL CAVITY LINER Specialites Septodont EJK Class II 1991-09-30
K913087 DENTAL FLOSS Westone Products , Ltd. JES Class I 1991-09-30
K913152 WHITER BITER CROWN George M. Wilson, Dds ELZ Class I 1991-09-30
K910427 MEMFIX SCREWS W. L. Gore & Associates, Inc. DZL Class II 1991-09-30
K911323 FLUX-N-ALL Precident Corp. EJH Class II 1991-09-30
K911399 NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) Aequitron Medical, Inc. DZD Class I 1991-09-19
K912945 SATIN PROPHYLAXIS PASTE Dentsply Intl. EJR Class I 1991-09-16
K911208 TIN COATED DENTAL BURS Surgical Precision Instruments, Corp. EJL Class I 1991-09-16
K912686 WHITER BITER CROWN George M. Wilson, Dds ELZ Class I 1991-09-16
K913070 X-L (DW228-14A) AND X-LX (DW228-24A) Ivoclar North America, Inc. EJS Class II 1991-09-13
K910475 DENTAL NEEDLE PROTECTIVE SYSTEM Health Technology Systems, Inc. DZM Class I 1991-09-13
K913232 ULTRACROWN(TM) PD DENTAL ALLOY Dentsply Intl. EJS Class II 1991-09-06
K913168 SALIBAG Nix Co. , Ltd. EGZ Class I 1991-09-06
K911282 PULPDENT ENAMEL BONDING AGENT Pulpdent Corp. KLE Class II 1991-09-06
K913160 ID-TAB Nix Co. , Ltd. EGZ Class I 1991-09-06
K905034 HD-4 CROWN & BRIDGE ALLOY Ho Dental Co., Inc. EJH Class II 1991-09-05
K912435 DENTAL CONNECTOR PRECISION ATTACHMENT Metalor Dental USA Corp. EGG Class I 1991-08-28
K912788 CURAY SUPPORT Scientific Pharmaceuticals, Inc. EBF Class II 1991-08-23
K910676 INTRAORAL DENTAL WAX Pemaco, Inc. EGD Class I 1991-08-21
K912820 POLYESTER RESIN HAND MOLDED TRAY E&D Dental Products, Inc. EBH Class I 1991-08-21
K911936 OSTEOMED SBF SYSTEM (SBF) Osteomed Corp. DZL Class II 1991-08-21
K912707 CLEARFIL LINER BOND SYSTEM Kuraray Co. KLE Class II 1991-08-20
K912708 CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM Kuraray Co. EBF Class II 1991-08-20
K912493 DEGUBOND LITE Degussa AG EJS Class II 1991-08-20
K912721 AUROFILM MP Metalor Dental USA Corp. EJT Class II 1991-08-20
K911165 SCREW, BONE, MAXILLOFACIAL Tekno-Medical DZL Class II 1991-08-20
K912720 ENDO-CORE Metalor Dental USA Corp. ELR Class I 1991-08-20
K912989 PLANUSTAR AND DENS NOBILIS DENTURE TEETH Wilde-USA, Inc. EMI Class I 1991-08-16
K911674 CERAPLUS Metalor Dental USA Corp. EJS Class II 1991-08-16
K910611 NOBELPHARMA CERAONE ABUTMENT SYSTEM Nobelpharma USA, Inc. DZE Class II 1991-08-16
K911669 CERAPALL 6 Metalor Dental USA Corp. EJS Class II 1991-08-16
K905223 OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS Universal Implant Systems, Inc. DZE Class II 1991-08-16
K912171 PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE Jack James EJF Class I 1991-08-13
K912313 SOLCHROM-PAL Metalor Dental USA Corp. EJT Class II 1991-08-09
K912305 STANDARD S3 Metalor Dental USA Corp. EJS Class II 1991-08-09
K912308 STANDARD S32 Metalor Dental USA Corp. EJS Class II 1991-08-09
K912302 VACU 2 Metalor Dental USA Corp. EJS Class II 1991-08-09
K912307 STANDARD S31 Metalor Dental USA Corp. EJS Class II 1991-08-09
K912497 IONOBOND Voco GmbH EMA Class II 1991-07-30
K912194 PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE Jelenko Co. EJS Class II 1991-07-30
K912195 PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE Jelenko Co. EJS Class II 1991-07-30
K912495 IONOSEAL Voco GmbH EJK Class II 1991-07-30
K912485 COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC Coltene/Whaledent, Inc. ELW Class II 1991-07-25
K905418 GATES GLIDDEN DRILLS The Hygenic Corp. DZA Class I 1991-07-25
K910090 DIMAC WIRES Instrumentations Unltd. DYX Class II 1991-07-25
K911961 BRANEMARK SYSTEM-5.0MM FIXTURE Nobelpharma USA, Inc. DZE Class II 1991-07-25
K912256 PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT Lee Pharmaceuticals KLE Class II 1991-07-24
K912473 ACCU-PLACER TM KIT Hu-Friedy Mfg. Co., Inc. EKJ Class I 1991-07-24
K912786 W-H TOPAIR DENTAL HANDPIECE Sabra-The Dental Products Group EFB Class I 1991-07-17
K911418 GUM MASSAGER Burn-Henderson Partnership JET Class I 1991-07-17
K911214 NUTIP (TM) SYRINGE SHIELD Western M/D, Inc. EKJ Class I 1991-07-17
K910795 COMFOR-DENT DENTURE LINER Comfort Acrylics Co. EBI Class II 1991-07-11
K911671 CERADELTA Metalor Dental USA Corp. EJS Class II 1991-07-10
K911643 ABIODENT PERIOTEMP(R) SYSTEM Abiomed, Inc. EIL Class I 1991-07-09
K904450 BIOCERAM DENTAL IMPLANT, SERIES II Kyocera America, Inc. DZE Class II 1991-07-09
K910610 INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT Bausch & Lomb, Inc. JEQ Class I 1991-07-09
K903488 MERIDIEN DENTAL SYSTEMS Anco Merchandise Co., Ltd. JEQ Class I 1991-07-09
K911286 PULPDENT ORTHODONTIC BRACKET ADHESIVE Pulpdent Corp. DYH Class II 1991-07-05
K902331 BUD DENTAL IMPLANT SYSTEM Bud Industries, Inc. DZE Class II 1991-07-05
K903515 HH-1119 HEALING HEAD Minimatic Implant Technology DZE Class II 1991-07-04
K911594 ORALCAM Charmac Group, Inc. EIA Class I 1991-07-03
K912315 V-DELTA S1 Metalor Dental USA Corp. EJS Class II 1991-07-02
K912314 800 SOLDER Metalor Dental USA Corp. EJS Class II 1991-07-02
K911545 V-DELTA Metalor Dental USA Corp. EJS Class II 1991-07-02
K912567 CONICAST, INTRACAST, OMECAST Metalor Dental USA Corp. EGG Class I 1991-07-02
K911244 VLC GLASS IONOMER LINER Dentsply Intl. EJK Class II 1991-06-28
K911668 CERAPALL 2 Metalor Dental USA Corp. EJS Class II 1991-06-27
K911677 SELECTOR 3 Metalor Dental USA Corp. EJS Class II 1991-06-27
K911675 PAGALIN 2 Metalor Dental USA Corp. EJS Class II 1991-06-27
K912304 STANDARD S2 Metalor Dental USA Corp. EJS Class II 1991-06-26
K912300 VS11 Metalor Dental USA Corp. EJS Class II 1991-06-26
K912303 STANDARD S1 Metalor Dental USA Corp. EJS Class II 1991-06-26
K912309 STANDARD S33 Metalor Dental USA Corp. EJS Class II 1991-06-26
K912297 VS1G Metalor Dental USA Corp. EJT Class II 1991-06-26
K912298 VS1 Metalor Dental USA Corp. EJS Class II 1991-06-26
K912299 VS1B Metalor Dental USA Corp. EJS Class II 1991-06-26
K912306 STANDARD S4 Metalor Dental USA Corp. EJS Class II 1991-06-26
K912149 HARDCOATED PLASTIC FILLING INSTRUMENT Premier Dental Products Co. EKJ Class I 1991-06-24

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