meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
38
Latest Decision
2004-03-26

Clearances · page 56 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K033970 CLEARFIL PHOTO CORE PLT Kuraray Medical, Inc. EBF Class II 2004-03-26
K031421 ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) Nakanishi, Inc. ELC Class II 2004-03-26
K040053 PRECISION VPS IMPRESSION MATERIAL Discus Dental, Inc. ELW Class II 2004-03-25
K040618 LED TURBO Apoza Enterprise Co., Ltd. EBZ Class II 2004-03-25
K033994 NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE Novabone Products, LLC LYC Class II 2004-03-25
K034035 3I PATIENT-SPECIFIC OVERDENTURE BAR Implant Innovations, Inc. NHA Class II 2004-03-24
K040691 INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D Win-Us Technology Co., Ltd. EIA Class I 2004-03-23
K034045 ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 Oral Osteodistraction, L.P. MQN Class II 2004-03-23
K040205 INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS Intra-Lock International NHA Class II 2004-03-22
K040548 AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE Harry J. Bosworth Co. DYH Class II 2004-03-19
K040547 AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE Harry J. Bosworth Co. DYH Class II 2004-03-19
K034024 TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS Bisco, Inc. EBI Class II 2004-03-19
K040539 ELLIPTIC MATRIX Institut Straumann AG NHA Class II 2004-03-18
K040420 DUCERAM PLUS CERAMIC SYSTEM Dentsply Intl. EIH Class II 2004-03-18
K040421 DUCERAGOLD PORCELAINS Dentsply Intl. EIH Class II 2004-03-18
K033729 COLLAGEN DENTAL WOUND DRESSINGS Collagen Matrix, Inc. LYC Class II 2004-03-17
K040551 COLTOLUX LED CURING LIGHT Coltene/Whaledent, Inc. EBZ Class II 2004-03-15
K021569 RESTFUL NIGHTS, IST-APPLIANCE Ottawa Dental Laboratory LRK Class II 2004-03-15
K040473 ORAVIVE TOOTH REVITALIZING PASTE Novamin Technology, Inc. LBH Class II 2004-03-10
K034067 ZTI IMPLANTS SYSTEM, DRM IMPLANTS Drm Research Laboratories, Inc. DZE Class II 2004-03-08
K034014 SPI CONTACT DENTAL IMPLANT Thommen Medical AG DZE Class II 2004-03-05
K040436 SIMIDUR SUPERIOR Wieland Dental + Technik GmbH & Co. KG EJS Class II 2004-03-05
K040180 CONTINUM V Aalba Dent, Inc. EJH Class II 2004-03-04
K032454 SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) Bio-Lok Intl., Inc. DZE Class II 2004-03-04
K040179 CONTINUM Aalba Dent, Inc. EJH Class II 2004-03-03
K040043 NDX-40 ALLOY Heraeus Kulzer, Inc. EJT Class II 2004-03-03
K034049 HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM Heraeus Kulzer,GmbH EJT Class II 2004-03-01
K033764 SP NEWTRON MODULE Satelec ELC Class II 2004-03-01
K040278 PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE Novabone Products, LLC LYC Class II 2004-03-01
K033697 POWER LED Dental Products of USA, Inc. EBZ Class II 2004-02-27
K034027 KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM KLS-Martin L.P. MQN Class II 2004-02-27
K033689 OSSTELL MENTOR RFA Integration Diagnostics, Ltd. EKX Class I 2004-02-26
K032625 ORTHODONTIC COMPOSITE BRACKET SYSTEM Ultradent Products, Inc. DYW Class II 2004-02-26
K033767 DUAL TOP ANCHOR SYSTEM SCREWS Jeil Medical Corporation DZE Class II 2004-02-24
K033996 HERMES 3M Espe AG Dental Products EBF Class II 2004-02-24
K033812 SIROAIR L AIR SCALER Sirona Dental Systems GmbH EFB Class I 2004-02-23
K040272 SYNTHES (USA) CRANIOFACIAL PLATES Synthes (Usa) JEY Class II 2004-02-23
K033724 NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236 Nobel Biocare Uas, Inc. NHA Class II 2004-02-23
K033690 TROPHYPAN AND TROPHYPAN C Trophy Radiologie EHD Class II 2004-02-20
K033974 HERMES BOND 3M Espe AG Dental Products KLE Class II 2004-02-06
K033213 CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS Codent Technical Industry Co., Ltd. EFB Class I 2004-02-06
K032562 PROCEARA COPINGS AND PONTIC Nobel Biocare AB ELL Class II 2004-02-06
K033823 RESPIRONICS CUSTOM II ORAL APPLIANCE Respironics, Inc. LRK Class II 2004-02-06
K030685 TEETH IN AN HOUR - ARK IMPLANT CONCEPT Nobel Biocare AB DZE Class II 2004-02-06
K033822 RESPIRONICS CUSTOM I ORAL APPLIANCE Respironics, Inc. LRK Class II 2004-02-06
K033703 IDEAL 1 ORTHODONTIC BRACKET ADHESIVE Dentsply Intl. DYH Class II 2004-02-06
K032416 VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN Shofu Dental Corp. EIH Class II 2004-02-05
K033751 AEGIS PIT & FISSURE SEALANT WITH ACP Harry J. Bosworth Co. EBC Class II 2004-02-05
K040098 VARNISHAMERICA Medical Products Laboratories, Inc. LBH Class II 2004-02-04
K033419 STV PRO 2 Trophy Radiologie EIA Class I 2004-02-02
K033808 GRADIA GUM GC America, Inc. EBF Class II 2004-02-02
K034022 UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES Diamodent DZE Class II 2004-01-30
K033120 SCALETRON PIEZO ULTRASOUND SCALER Pac-Dent International (Suzhou), Ltd. ELC Class II 2004-01-29
K033938 CLEARFIL PROTECT BOND Kuraray Medical, Inc. KLE Class II 2004-01-29
K032263 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR Implant Innovations, Inc. DZE Class II 2004-01-28
K033309 PREMIER IMPLANT CEMENT, MODEL 3001450 Premier Dental Products Co. EMA Class II 2004-01-26
K031809 PERIO PROTECT TRAY Perio Protect, LLC KMT Class I 2004-01-23
K033760 ONE COAT SE BOND Coltene/Whaledent, Inc. KLE Class II 2004-01-23
K033667 CARRARA PRESS SYSTEM Dentsply Intl. EIH Class II 2004-01-23
K024252 MATCH MASTER LOW FUSION PORCELAIN Davis Schottlander & Davis, Ltd. EIH Class II 2004-01-22
K033632 VARIFLEX Great Lakes Orthodontics, Ltd. EBI Class II 2004-01-21
K033227 LUXAFORM PLUS Dmg USA, Inc. EBG Class II 2004-01-16
K033628 ARTIC Heraeus Kulzer, Inc. ELM Class II 2004-01-16
K033521 BISBLOCK Bisco, Inc. EJK Class II 2004-01-16
K033585 DIAPEX Bisco, Inc. KIF Class II 2004-01-16
K033675 PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER Sirona Dental Systems GmbH KOJ Class II 2004-01-15
K033432 LEXATITE QUICK ACRYLIC Imtec Corp. EBG Class II 2004-01-15
K033279 GOLD DENTAL CASTING ALLOYS Bego U.S.A. EJT Class II 2004-01-15
K033472 TESCERA U-BAR AND BARRELS Bisco, Inc. EBI Class II 2004-01-15
K033773 CONCEPT HP ADD-ON; CONCEPT HP ENAMEL Ivoclar Vivadent, AG EBF Class II 2004-01-15
K033483 KLS-MARTIN ORTHO ANCHORAGE SYSTEM KLS-Martin L.P. DZE Class II 2004-01-15
K033815 BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN Geistlich-Pharma NPM Class II 2004-01-15
K033215 PREPAIR Danville Materials, Inc. KOJ Class II 2004-01-09
K033449 PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES Professional Dental Technologies Therapeutics, Inc. EJR Class I 2004-01-07
K033922 MODIFICATION TO ITI DENTAL IMPLANT SYSTEM Institut Straumann AG DZE Class II 2004-01-07
K031936 OSTEOMED ORTHODONTIC SCREW SYSTEM Osteomed LP DZE Class II 2004-01-07
K033665 VENUS FLOW Heraeus Kulzer, Inc. EBF Class II 2003-12-30
K033147 CLEARTOOTH DIGITAL X-RAY SYSTEM Cleartooth Electronics, Inc. MUH Class II 2003-12-30
K033356 VERASOFT ES Aalba Dent, Inc. EJH Class II 2003-12-30
K031322 INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS Intra-Lock International DZE Class II 2003-12-23
K033045 DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST American Green Dent. Mfg, Inc. EJH Class II 2003-12-23
K031968 CERABIEN ZR Noritake Co., Inc. EIH Class II 2003-12-22
K033267 EPRICORD Kuraray Medical, Inc. EBF Class II 2003-12-22
K032925 B&R DEVICE Ronvig A/S EGS Class I 2003-12-22
K033629 VERSYO.BOND Heraeus Kulzer, Inc. EBI Class II 2003-12-22
K033795 PLASMACURE BXE Eele Laboratories, LLC EBZ Class II 2003-12-19
K033020 IMPAK ACRYLIC REPAIR RESIN LIQUID Cmp Industries, LLC EBI Class II 2003-12-19
K033551 EVOLVE Reliance Orthodontic Products, Inc. DYH Class II 2003-12-16
K033640 SIROSON L AND SIROSONIC L ULTRASONIC SCALERS Sirona Dental Systems GmbH ELC Class II 2003-12-12
K033392 IMMEDIATE STABILIZING IMPLANT (ISI) O Co., Inc. DZE Class II 2003-12-10
K033110 C-GRAFT The Clinician'S Preference, LLC LYC Class II 2003-12-10
K032757 A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE A-Dec, Inc. EIA Class I 2003-12-10
K032953 EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT Pulpdent Corporation KLE Class II 2003-12-10
K031094 FLUID FILLED TEETHERS Royal King Infant Products Co. , Ltd. KKO Class II 2003-12-08
K033520 BLUEPHASE Ivoclar Vivadent, Inc. EBZ Class II 2003-12-05
K033705 BOBCAT PRO SCALER SYSTEM, MODEL G-130 Dentsply International ELC Class II 2003-12-04
K032756 A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 A-Dec, Inc. EIA Class I 2003-12-04
K032626 PERMAQUICK SE BONDING SYSTEM Ultradent Products, Inc. KLE Class II 2003-12-03
K030485 NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR Newmedical Technology, Inc. MQN Class II 2003-12-03
K032572 A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT A-Dec, Inc. EBW Class I 2003-12-03

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