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Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
40
Latest Decision
1991-06-24

Clearances · page 98 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K911506 MODEL 2100 PORTABLE FIELD UNIT Dntl Corp. EIA Class I 1991-06-24
K901552 (CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE Nobelpharma USA, Inc. EJH Class II 1991-06-24
K911757 MAXIBOND Argen Precious Metals, Inc. EJS Class II 1991-06-18
K911670 CERAPALL Metalor Dental USA Corp. EJS Class II 1991-06-18
K911842 3M LUTING CEMENT, PASTE A AND B 3M Company EMA Class II 1991-06-17
K911112 DEVICE PART NUMBERS: - 1400 SERIES Minimatic Implant Technology DZE Class II 1991-06-10
K905303 ABUTMENT GLO Implant Innovations International, Inc. EJR Class I 1991-06-10
K911287 PULPDENT SEAL RITE Pulpdent Corp. EBC Class II 1991-06-10
K911937 OSTEOMED IB DRILL Osteomed Corp. EFB Class I 1991-06-10
K912037 DEGULUX LIGHT CURING UNIT Degussa AG EBF Class II 1991-06-07
K905058 PALAVIT L Kulzer, Inc. EBH Class I 1991-06-06
K910166 CUTTERSIL XL Heraeus Kulzer, Inc. ELW Class II 1991-06-06
K904928 PALAVIT GLC Kulzer, Inc. EGD Class I 1991-06-06
K910465 MELIODENT, DENTURE RESIN Heraeus Kulzer, Inc. EBI Class II 1991-06-06
K910165 CUTTERSIL MUCOSA Heraeus Kulzer, Inc. ELW Class II 1991-06-06
K910189 PERFOURM PUTTY SOFT Heraeus Kulzer, Inc. ELW Class II 1991-06-06
K910360 CUTTERSIL FUNCTION ACTIVATOR Heraeus Kulzer, Inc. ELW Class II 1991-06-06
K911259 HYDENT Pascal Co., Inc. EFH Class I 1991-06-06
K904251 NEW TRIAD VLC CROWN & BRIDGE PROVISIONAL MATERIAL Dentifax Intern, Inc. EBG Class II 1991-06-06
K911546 INLAY 90 Metalor Dental USA Corp. EJT Class II 1991-06-06
K885158 MENSOR COMPLIANT KEEPER Merrill C. Mensor, Jr., D.D.S. DZE Class II 1991-06-06
K910263 CHARISMA Kulzer, Inc. EBF Class II 1991-06-03
K910446 STABIDENT LOCAL ANESTHESIA SYSTEM Fairfax Dental, Inc. DZM Class I 1991-06-03
K904813 VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. Alpha-Dent EBF Class II 1991-05-31
K911821 THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST Dentecon, Inc. EJH Class II 1991-05-30
K911284 PULPDENT DIAMOND POLISH Pulpdent Corp. EJR Class I 1991-05-30
K910627 ALPHA-FIL, ALPHA-BASE & ALPHA-SILVER, MODIFICATION Foremost Mfg., Inc. EBF Class II 1991-05-29
K911271 ADHESIVE PRECOATED BRACKETS Unitek Corp. DYH Class II 1991-05-29
K911524 PALFIQUE ESTELITE Tokuyama America, Inc. EBF Class II 1991-05-29
K911042 GAMMAT ELECTROFORMED GOLD COPING Gramm Surface Technology, Inc. EJT Class II 1991-05-29
K905071 MX CYCLER Dakmed, Inc. EKX Class I 1991-05-28
K910794 SMALL INSTRUMENT STERILIZATION/BUR BOX Brevet, Inc. EJL Class I 1991-05-23
K911701 G-FLOSS & G-FLOSS II Implant Innovations International, Inc. JES Class I 1991-05-15
K911525 TOKUSO LIGHT BOND Tokuyama America, Inc. KLE Class II 1991-05-15
K905657 SONOPAK/QS, SONOPAK Bioresearch NFQ Class I 1991-05-15
K911068 29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM Micro Motors, Inc. EFB Class I 1991-05-15
K911281 PULPDENT PIC N STIC Pulpdent Corp. EKJ Class I 1991-05-15
K911072 SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR A & F Products EHZ Class I 1991-05-15
K911470 BUFFING FLOSS Lamar Industries JES Class I 1991-05-15
K902968 BIO-VENT-X ENDOSSEOUS HA COATED DENTAL IMPLANTS Core-Vent Corp. DZE Class II 1991-05-15
K904135 FOUNDATION HYBRID COMPOSITE Nulite Systems Research EBD Class II 1991-05-15
K910813 MET-ETCH Gresco Products, Inc. EBC Class II 1991-05-07
K910432 HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER Lifecore Biomedical, Inc. LYC Class II 1991-05-01
K910467 ARGIPLUS Argen Precious Metals, Inc. EJS Class II 1991-04-30
K911531 V-SUPERGOLD Metalor Dental USA Corp. EJT Class II 1991-04-29
K904707 BC 1208 IMPLANT, THREADED EXTERNAL HEX Minimatic Implant Technology DZE Class II 1991-04-29
K911537 V-DELTA, SF Metalor Dental USA Corp. EJT Class II 1991-04-29
K911538 AUROFLUID 2 Metalor Dental USA Corp. EJT Class II 1991-04-29
K911539 AUROFLUID 3 Metalor Dental USA Corp. EJT Class II 1991-04-29
K911536 V-DELTABOND Metalor Dental USA Corp. EJT Class II 1991-04-29
K911541 PONTOR 4 CF Metalor Dental USA Corp. EJT Class II 1991-04-29
K911543 SOLARO 3 Metalor Dental USA Corp. EJT Class II 1991-04-29
K911534 V44 Metalor Dental USA Corp. EJT Class II 1991-04-29
K905582 POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND Milton Hodosh, M.D. EBC Class II 1991-04-29
K905702 NEW TRIAD TRANSHEET DENTURE BASE MATERIAL Dentsply Intl. EBI Class II 1991-04-29
K910719 SILICOATER MD Kulzer, Inc. EMA Class II 1991-04-29
K911544 SOLARO 4 Metalor Dental USA Corp. EJT Class II 1991-04-29
K911532 V-SUPER Metalor Dental USA Corp. EJT Class II 1991-04-29
K911540 PROTH-AURO 22 Metalor Dental USA Corp. EJT Class II 1991-04-29
K911542 PONTOR 2 Metalor Dental USA Corp. EJT Class II 1991-04-29
K910860 ALL-BOND 2 Bisco, Inc. KLE Class II 1991-04-29
K911535 V-CLASSIC Metalor Dental USA Corp. EJT Class II 1991-04-29
K905039 IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER Minimatic Implant Technology DZE Class II 1991-04-29
K904090 ORTHODONTIC BONDING ADHESIVE CONTROL Lancer Orthodontics, Inc. DYH Class II 1991-04-29
K911530 V-GNATHOS Metalor Dental USA Corp. EJT Class II 1991-04-29
K911533 V92 Metalor Dental USA Corp. EJT Class II 1991-04-29
K905449 ELECTROSONOGRAM ESG-1 Myo-Tronics, Inc. NFQ Class I 1991-04-26
K905470 STANDARD RUBBER DAM WITH OR WITHOUT FRAMES Elastomade Accessories Sdn Bhd EIE Class I 1991-04-25
K903043 ICT-1108 IMPLANT- THREADED (CEMENT TYPE ABUTMENT) Minimatic Implant Technology DZE Class II 1991-04-19
K903046 IDT-1104 IMPLANT (SCREW-IN-THREADED) Minimatic Implant Technology DZE Class II 1991-04-19
K904876 DW237 Ivoclar North America, Inc. EJS Class II 1991-04-17
K910832 OXYFRESH OXYCARE 3000 Oxyfresh EFS Class I 1991-04-17
K903298 DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP Micro Motors, Inc. ELC Class II 1991-04-16
K901955 PERIOGARD(R) PERIOPEN Colgate-Palmolive Co. EFS Class I 1991-04-15
K910569 TYCERAMIC Jeneric/Pentron, Inc. ELL Class II 1991-04-15
K904705 BC 1206 IMPLANT - INSERT TYPE Minimatic Implant Technology DZE Class II 1991-04-12
K902974 COOLING TEETHERS Realgrow Intl. Corp. KKO Class II 1991-04-03
K902018 DENTAURUM CERAMIC DEBONDING UNIT Dentauraum, Inc. EKS Class I 1991-04-03
K910424 TEETHMATE-F Kuraray Co. EMA Class II 1991-04-03
K910288 NONSTAINING ALASTIKS Unitek Corp. EJF Class I 1991-03-29
K910628 ALL BOND LINER-F Bisco, Inc. KLE Class II 1991-03-29
K905604 VISIO-GEM ART-SYSTEM Espe GmbH (Us) EBF Class II 1991-03-29
K910224 THERMAPREP Tulsa Dental Products, Ltd. EKM Class I 1991-03-29
K904710 BC 1219 HEALING HEAD Minimatic Implant Technology DZE Class II 1991-03-29
K904805 TENTATIVE OPERATING NAME-JAZZ BAND Franklin M. Din D.M.D., P.A. EBF Class II 1991-03-29
K903211 O BUTMENT O Co., Inc. DZE Class II 1991-03-29
K904712 BC 1221 BALL OVERDENTURE ATTACHMENT Minimatic Implant Technology DZE Class II 1991-03-29
K905204 DW 236 Ivoclar North America, Inc. EJJ Class II 1991-03-29
K910216 STEADFAST DENTURE ADHESIVE POWDER Stiefel Research Institute, Inc. KOM Class I 1991-03-29
K903986 SWIRL PROPHYLAXIS PASTE Bio-Medica Concepts EJR Class I 1991-03-28
K904709 BC 1213 HEALING SCREW Minimatic Implant Technology DZE Class II 1991-03-21
K904704 BC 1203 ABUTMENT TAPERED SHOULDER Minimatic Implant Technology DZE Class II 1991-03-21
K904706 BC 1207 ABUTMENT FIXED Minimatic Implant Technology DZE Class II 1991-03-21
K904708 BC 1211 ABUTMENT, FIXED TRANSFER PIN, INDIRECT Minimatic Implant Technology DZE Class II 1991-03-21
K905723 IONOSEAL Micro-Vac, Inc. EJK Class II 1991-03-15
K910803 ENAMEL ETCHING GEL Gresco Products, Inc. DYH Class II 1991-03-15
K910068 SPECTRAMAT Ivoclar North America, Inc. EBZ Class II 1991-03-15
K910632 ACCU-MIX AMALGAMATOR Wykle Research, Inc. EFD Class I 1991-03-15
K910065 GDC-3200 DENTAL SOLDER Deringer-Ney, Inc. EJT Class II 1991-03-15
K904703 BC-1201 CAST ABUTMENT Minimatic Implant Technology DZE Class II 1991-03-15

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