meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
38
Latest Decision
2012-08-08

Clearances · page 34 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K112162 CONICAL CONNECTION IMPLANTS Mis Implants Technologies , Ltd. DZE Class II 2012-08-08
K121698 NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN Dentsply International, Inc. EJR Class I 2012-08-06
K112532 ET II BIO-SA FIXTURE SYSTEM Hiossen, Inc. DZE Class II 2012-08-06
K120414 OSSEOSPEED PLUS Astra Tech AB DZE Class II 2012-07-31
K120283 DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT Novocol, Inc. EMA Class II 2012-07-31
K110425 HC-BIOS DENTAL IMPLANT Hung Chun Bio-S Co., Ltd. DZE Class II 2012-07-27
K121359 IPS 99 ONE AND IPS 99 CERAM Ivoclar Vivadent, AG EIH Class II 2012-07-27
K121583 CLEARFIL MAJESTY FLOW Kuraray Noritake Dental, Inc. EBF Class II 2012-07-25
K120914 FLEXITIME FAST & SCAN LIGHT FLOW Heraeus Kulzer, LLC ELW Class II 2012-07-25
K120176 SENZZZZZ AWAY Centrix, Inc. LBH Class II 2012-07-25
K111465 COMPOTHIXO Kerrhawe SA DZN Class I 2012-07-25
K121282 MICROLUX/DL MICROLUX/BLU BIO/SCREEN Addent, Inc. NXV Class II 2012-07-24
K113574 FLEXITIME MONOPHASE PRO SCAN Heraeus Kulzer, LLC ELW Class II 2012-07-13
K120263 VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM Genoray Co., Ltd. MUH Class II 2012-07-10
K120338 ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA Astra Tech, Inc. NHA Class II 2012-07-05
K120530 DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S Dentin Implants Technologies , Ltd. DZE Class II 2012-07-05
K103577 TRINON Q & Q3 IMPLANT SYSTEM Trinon Titanium GmbH DZE Class II 2012-07-03
K121574 SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM Synthes, Inc. JEY Class II 2012-06-29
K113512 BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM Biomet Microfixation JEY Class II 2012-06-29
K120218 TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE) Palm Beach Dental Supply D/B/A Tek USA EFB Class I 2012-06-29
K120372 DR GREENBURGS HYBRID VACUUM Always More Marketing, Inc. LRK Class II 2012-06-27
K120243 GAM-200 GC America, Inc. EMA Class II 2012-06-27
K120371 DR GREENBURGS HYBRID ACRYLIC Always More Marketing, Inc. LRK Class II 2012-06-27
K120134 IPS E.MAX PRESS MULTI Ivoclar Vivadent, AG EIH Class II 2012-06-25
K120975 CS 8100 CS 8100 ACCESS Trophy MUH Class II 2012-06-22
K121165 BEAM BRUSH/BEAM APP Beam Technologies, LLC EFW Class I 2012-06-21
K120048 DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S Drfp , Ltd. KIF Class II 2012-06-20
K112024 TI-MAX X450 Nakanishi, Inc. EFB Class I 2012-06-20
K120503 CMI IMPLANT IS II ACTIVE Neobiotech Co., Ltd. DZE Class II 2012-06-18
K120159 BEAUTICEM SA Shofu Dental Corporation EMA Class II 2012-06-18
K113152 ULTRASONIC SURGERY MACHINE Dmetec.Co., Ltd. DZI Class II 2012-06-14
K120695 DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT Dentist IN A Box Pty., Ltd. EMB Class I 2012-06-12
K113022 PURESLEEP Sleep Science Partners, Inc. LRK Class II 2012-06-11
K120784 TUFF-TEMP 2.0 Pulpdent Corporation EBG Class II 2012-06-08
K120432 TELIO CS CEM IMPLANT Ivoclar Vivadent, AG EMA Class II 2012-06-08
K112627 MILLENIUM ANTI-SNORING DEVICE Millenium Dental Laboratory, Inc. LQZ Class II 2012-06-06
K120852 ZIRCONIA BLANKS (ZIRCOSTAR) Kerox, Ltd. EIH Class II 2012-06-06
K120198 LOCATOR OVERDENTURE IMPLANT SYSTEM Zest Anchors, LLC DZE Class II 2012-06-06
K121131 BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM Straumann USA DZE Class II 2012-06-06
K121318 PROSOFT Perma Laboratories EBP Class II 2012-06-06
K120471 MACH BRACKETS BRIGHT BRACKETS World Bio Tech Co., Ltd. NJM Class II 2012-06-04
K112766 SNORKEL Fellmar Company LQZ Class II 2012-06-04
K120779 STRUCTUR 3 Voco GmbH EBG Class II 2012-06-01
K111798 STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... Sterngold Dental, LLC DZE Class II 2012-06-01
K120620 CLEAN AND BOOST Apex Dental Materials, Inc. KLE Class II 2012-05-31
K121340 SOMNODENT G2 Somnomed, Inc. LRK Class II 2012-05-30
K120271 ARTISAN SPACE MAINTENANCE SYSTEM Medtronic Sofamor Danek USA, Inc. JEY Class II 2012-05-30
K120601 GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O Geistlich Pharma AG NPM Class II 2012-05-24
K120767 ES BOND Spident Co., Ltd. KLE Class II 2012-05-24
K112585 TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM Adin Dental Implants System, Ltd. DZE Class II 2012-05-24
K120013 TEMPSPAN CLEAR MATRIX Pentron Clinical ELW Class II 2012-05-22
K120619 ORTHODONTIC FLOWABLE BRACKET ADHESIVE Novocol, Inc. DYH Class II 2012-05-21
K120404 MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH Merz Dental GmbH ELM Class II 2012-05-21
K112457 LEFORTE SYSTEM BONE PLATE & SCREW Arkin Consulting Group JEY Class II 2012-05-18
K120736 SR PHONARES II Ivoclar Vivadent, AG ELM Class II 2012-05-14
K120521 GC BLUE SILICONE GC America, Inc. ELW Class II 2012-05-10
K120106 APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM Apixia, Inc. MUH Class II 2012-05-07
K112279 QUANTUM DENTAL IMPLANT SYSTEM Quantum Bioengineering, Ltd. DZE Class II 2012-05-04
K112665 TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE J. Morita USA, Inc. EKX Class I 2012-05-04
K120768 ES FLOW Spident Co., Ltd. EBF Class II 2012-05-03
K120438 FLASH (DIFFERENT MATERIALS) 3M Deutschland GmbH ELW Class II 2012-05-02
K120043 CSM INTERNAL-R IMPLANT SYSTEM Csm Implant DZE Class II 2012-04-27
K120037 BLUWHITE DIAMOND DENTAL BURS MODIFIED Beavers Dental, Div. Sybron Canada, Ltd. DZP Class I 2012-04-20
K112795 PALTOP DENTAL IMPLANT SYSTEM Paltop Advanced Dental Solutions, Ltd. DZE Class II 2012-04-20
K112440 AB DENTAL DEVICES IMPLANTS AND ACCESSORIES A.B. Dental Devices , Ltd. DZE Class II 2012-04-18
K112305 VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES Thunder Tiger Corp. EGS Class I 2012-04-17
K113608 DEFLEX Nuxen S.R.L. EBI Class II 2012-04-10
K110481 TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE Asi Medical, Inc. EIA Class I 2012-04-05
K120003 NUCAL Pulpdent Corporation EJK Class II 2012-04-05
K113554 CMI IMPLANT IS SYSTEM Neobiotech Co., Ltd. DZE Class II 2012-04-05
K113674 SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT Handpiece Headquarters, Inc. - Hpr, Inc. EFB Class I 2012-04-05
K120378 PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S Kuraray Medical, Inc. EMA Class II 2012-03-30
K120213 ETCH-RITE SUPREME Pulpdent Corporation KLE Class II 2012-03-30
K113431 CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA Bettini S.P.A. EIH Class II 2012-03-30
K120379 PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S Kuraray Medical, Inc. EMA Class II 2012-03-30
K111549 ATTUNE SLEEP APNEA SYSTEM Apnicure, Inc. OZR Class II 2012-03-30
K112307 RESIGLASS PASTE Shofu Dental Corporation EMA Class II 2012-03-28
K113672 PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH Co., Ltd. MUH Class II 2012-03-27
K113247 ANESTHESIA INJECTION TOOL SET Ki Works Co., Ltd. EJI Class II 2012-03-27
K112064 RESORB X-G KLS-Martin L.P. JEY Class II 2012-03-23
K103704 REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP Zephyr Sleep Technologies, Inc. LRK Class II 2012-03-23
K113818 EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL Pulpdent Corporation EBC Class II 2012-03-21
K120453 FILTEK BULK FILL FLOWABLE RESTORATIVE 3M Espe Dental Products EBF Class II 2012-03-19
K113618 CLEARCORRECT SYSTEM Clearcorrect, Inc. NXC Class II 2012-03-19
K112078 ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) Maruchi KIF Class II 2012-03-19
K111541 ENDO-EXPRESS (R) HANDPIECE Essential Dental Systems, Inc. EGS Class I 2012-03-16
K113788 DEFLEX ACRILATO Nuxen S.R.L. EBI Class II 2012-03-16
K110337 UNIVERSAL MAXILLARY MOLAR Oco Biomedical DZE Class II 2012-03-16
K113575 HILLA DIGITAL TRANSFERS Hilla Technologies, Inc. EIH Class II 2012-03-07
K120109 SUPER SEAL TOOTH DESENSITIZER Phoenix Dental, Inc. LBH Class II 2012-03-07
K120318 VIVI ERGON-X HF Vivi S.R.L. MUH Class II 2012-03-06
K113711 LIME-LITE II Pulpdent Corporation EJK Class II 2012-03-05
K113655 TI-MAX X TURBINE Nakanishi, Inc. EFB Class I 2012-03-05
K113617 SPEE-DEE PATCH Pulpdent Corporation EBF Class II 2012-03-02
K111423 CS 1600 INTRAORAL CAMERA Carestream Health, Inc. NBL Class II 2012-03-02
K113003 ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... Astra Tech, Inc. NHA Class II 2012-03-01
K113569 APNEARX Apnea Science Corporation LRK Class II 2012-03-01
K112758 KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 Kat Implants, LLC DZE Class II 2012-02-23
K113430 PROULTRA PIEZO ULTRASONIC Satelec - Acteon Group ELC Class II 2012-02-23
K113222 ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE Nakamura Dental Handpiece Mfg. Co., Ltd. EFB Class I 2012-02-23

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