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Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
55
Latest Decision
1977-10-13

Clearances · page 126 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K771863 COLOR COTE Williams Gold Refining Co., Inc. EJT Class II 1977-10-13
K771853 PERMAGUM ADHESIVE Espe GmbH (Us) ELW Class II 1977-10-13
K771774 NEW BASE FOR ORTHODONTIC APPLIANCES Gac Intl., Inc. EJF Class I 1977-09-30
K771748 INTRA ORAL X-RAY CONES General Electric Co. EAH Class I 1977-09-28
K771747 PERIOSTEAL ELEVATOR Depuy, Inc. EMJ Class I 1977-09-28
K771749 AMALGAM DISPENSER New Dimensions IN Medicine, Inc. EHE Class I 1977-09-28
K771706 SAIF-BOW Northwest Orthodontics, Inc. DZB Class II 1977-09-20
K771658 IDENTOFLEX Cavitron Corp. EHJ Class I 1977-09-12
K771654 NIMETICAP Espe GmbH (Us) EBF Class II 1977-09-06
K771627 PERMAGUM Espe GmbH (Us) ELW Class II 1977-09-02
K771602 MYERSONS SPEC. CROWN & BRIDGE RESIN Howmedica Corp. EBG Class II 1977-08-30
K771406 GUTTA GUN Aus-Tex Dental Mfg. & Design EIC Class I 1977-08-26
K771596 WILL-CERAM W-3 Williams Gold Refining Co., Inc. EJS Class II 1977-08-26
K771398 SHELL VENEER L.D. Caulk Co. ELM Class II 1977-08-26
K771399 LIP & CHEEK RETRACTOR L.D. Caulk Co. EIG Class I 1977-08-26
K771402 NUVA-COTE (MODIFICATION TO) L.D. Caulk Co. EBC Class II 1977-08-26
K771530 TEMP. CROWN ACRYLIC RESIN J. Palmero Sales Co., Inc. EBG Class II 1977-08-25
K771556 EXR Litton Dental Products ELC Class II 1977-08-22
K771403 EASE (MODIFICATION TO) L.D. Caulk Co. EJJ Class II 1977-08-22
K771401 PROPHY PASTE L.D. Caulk Co. EJR Class I 1977-08-22
K771481 TONGUE BLADE HOLDER Welch Allyn, Inc. EMA Class II 1977-08-19
K771557 ULTRASON 990 Litton Dental Products ELC Class II 1977-08-19
K771176 GOTHIC ARCH TRACING Dentsply Intl. KZO Class I 1977-08-16
K771527 ACCU. CROWN COLD CURE Parker Laboratories, Inc. EBG Class II 1977-08-16
K771451 SCUTABOND Premier Dental Products Co. EMA Class II 1977-08-16
K771522 FORCEPS, STYLE #849 Premier Dental Products Co. EMH Class I 1977-08-16
K771347 R&R ALSTON CARBIDE BURS Ransom and Randolph EJL Class I 1977-08-03
K771404 NUVA-FIL COMPOSITE RESTORATIVE (MODI.) L.D. Caulk Co. EBF Class II 1977-08-03
K771366 INTERPLANTS Maurices J. Fagan, Jr. B.S., D.D.S. DZE Class II 1977-08-03
K771396 DISPENSER, MERCURY & TABLET/POWDER Johnson & Johnson Professionals, Inc. EHE Class I 1977-08-03
K771328 UVIOBOND Espe GmbH (Us) KLE Class II 1977-08-03
K771383 ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP Johnson & Johnson Professionals, Inc. EJJ Class II 1977-08-03
K771326 NIMETIC BONDING MATERIAL Espe GmbH (Us) KLE Class II 1977-08-02
K771266 STEAM STERILIZER Amsco Hospital Products Co. ECG Class I 1977-08-02
K771325 NIMETIC ETCHING GEL Espe GmbH (Us) KLE Class II 1977-08-02
K771327 UVIOFIL Espe GmbH (Us) EBC Class II 1977-08-02
K771185 PERIODONTIC TOOTHBRUSH, #0126-0190-00 Hoyt Laboratories EFW Class I 1977-07-15
K771110 HERITAGE SPECIAL ALLOY Howmedica Corp. EJT Class II 1977-07-15
K771183 TOOTHBRUSH, PEDODONTIC, #0126-0188-00 Hoyt Laboratories EFW Class I 1977-07-15
K771247 CORE MATERIAL Star Dental Mfg. Co. EBF Class II 1977-07-15
K771145 WILL-CERAM W-2 Williams Gold Refining Co., Inc. EJS Class II 1977-07-15
K771119 PASTES, RESTORATIVE & TINTED, DEBTAL Espe Dental Products EBF Class II 1977-07-15
K771179 BIOBOND MASTER STAIN AND GLAZE KIT Dentsply Intl. ELL Class II 1977-07-15
K771249 JOY LIGHT M.D. Intl., Inc. EAZ Class I 1977-07-15
K771252 CB600, TURBINE CONTROL BOL Litton Dental Products EIA Class I 1977-07-15
K771214 SUPERFINE DIAMONDS Den-Mat Corp. EJL Class I 1977-07-15
K771251 HU:500, HYGIENASSIST Litton Dental Products EIA Class I 1977-07-15
K771257 ACRY TEMP Interstate Dental Co., Inc. EBG Class II 1977-07-15
K771128 NEKO CERAMIC CONVENIENCE CROWNS Sterndent Corp. ELZ Class I 1977-07-15
K771248 SILICONE IMPRESSION MATEOIAL Interstate Dental Co., Inc. ELW Class II 1977-07-15
K771254 ACCU. CROWN COLD CURE Briar Cliff, Inc. EBG Class II 1977-07-15
K771184 TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 Hoyt Laboratories EFW Class I 1977-07-15
K771095 J HOOK HEADGEAR Northwest Orthodontics, Inc. DZB Class II 1977-06-24
K771076 ORTHODONTIC BRACKET ADHESIVE Lee Pharmaceuticals DYH Class II 1977-06-24
K771081 LITECAST CERAMIC Williams Gold Refining Co., Inc. EJH Class II 1977-06-24
K770413 CUSHIONS, DENTURE ADHESIVE, ALL-DAY Combe, Inc. EHS Class II 1977-06-24
K771077 ULTRAVIOLET RAD-EMITTING LAMP Lee Pharmaceuticals EBZ Class II 1977-06-24
K770749 TOOTHBRUSH, REACH Johnson & Johnson Professionals, Inc. EFW Class I 1977-06-20
K771011 ARTICULATING PAPER Parker Laboratories, Inc. EFH Class I 1977-06-20
K770997 PRO-CARE Young Dental Manufacturing Co. 1, LLC JEQ Class I 1977-06-20
K770990 DENTAL PLAQUE DISCLOSING AGENT Evident Dental Co. , Ltd. QJC Class I 1977-06-20
K770967 SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE National Patent Development Corp. EIC Class I 1977-06-20
K770932 GERAMCO LOW TEMP GLAZE Johnson & Johnson Professionals, Inc. EIH Class II 1977-06-03
K770931 APPLIC SYSTEM APPLIER, ESPE Espe GmbH (Us) EID Class I 1977-06-03
K770941 APPLIC SYSTEM ACTIVATOR, ESPE Espe GmbH (Us) EID Class I 1977-06-02
K770922 DENTAL RESTORATIVE IN CAPSULES Espe GmbH (Us) EBF Class II 1977-06-01
K770872 IMPRESSION MATERIAL, ALGINATE Espe GmbH (Us) ELN Class I 1977-06-01
K770923 ESPETEMP (TEMP. CEMENT) Espe GmbH (Us) EMA Class II 1977-06-01
K770813 ENDOGATOR Aus-Tex Dental Mfg. & Design EIC Class I 1977-05-20
K770685 LIGHT, EXAMINING, DENTAL, ULTRA VIOLET Parker Laboratories, Inc. EAQ Class II 1977-04-26
K770684 CROWN, ACRYLIC, CORAL BRAND, PREFORMED Parker Laboratories, Inc. ELZ Class I 1977-04-26
K770331 DIALYSIS, JET SYSTEM Janneck Ent. of Texas EKP Class I 1977-04-20
K770667 CHROMASCAN TM Sterndent Corp. KZN Class II 1977-04-20
K770642 SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE National Patent Development Corp. EIC Class I 1977-04-15
K770215 ACTIVATOR LIGHT Gte Sylvania, Inc. EBZ Class II 1977-04-15
K770600 OROPHARYNGEAL SUCTION AIRWAY W.H. Wall, D.D.S. EBR Class I 1977-04-08
K770464 TOOTHBRUSH, PLAK-A-DENT Smith, Ranscht, Pollock, Manos & Connor EFW Class I 1977-04-08
K770598 ENDODONTIC INSTRUMENTS, R&R CUTWELL Ransom and Randolph EKP Class I 1977-04-05
K770599 NUVA-LITE II PHOTO-CURE UNIT Dentsply Intl. EBZ Class II 1977-04-05
K770558 ISODYNE Hmw Industries ECO Class I 1977-04-05
K770556 PRO-KUP Dental Control Products EHK Class I 1977-03-24
K770492 CRACK DETECTOR, DEN-MAT Dey-Mat, Inc. EFH Class I 1977-03-21
K770469 CUTTER TUNGSTEN CARBIDE BURS Cutter Laboratories, Inc. EJL Class I 1977-03-16
K770440 IMPLANT, DENTAL, PYROLITE CARBON ENDO. General Atomic Co. DZE Class II 1977-03-15
K770345 X-RAY TUBE - PANOBEAM Thoro-Ray, Inc. EAP Class II 1977-03-08
K770367 ROOT CANAL FILES & REAMERS Cemco Tool Co., Inc. EKP Class I 1977-03-01
K770158 HEMOSTAT Deringer-Ney, Inc. EMD Class I 1977-01-31
K770152 AUTO-RINSE Dental Innovators, Inc. EHZ Class I 1977-01-31
K770160 CERAMIST BRUSH Deringer-Ney, Inc. KXR Class I 1977-01-31
K770129 SPRINT S-2 INSTRU. CENTER (MODEL 92329) Chemetron Health Systems EBW Class I 1977-01-28
K770117 HYGIENIC 5 & 6 RUBBER DAM FRAME Hygienic Dental Mfg., Co., The EJE Class I 1977-01-28
K770131 LEW PROSTHETIC LOCKING DEVICE Howmedica Corp. DZL Class II 1977-01-28
K770113 ESTILUX UV SYSTEM Degussa Dental, Inc. EBZ Class II 1977-01-28
K770116 PORTA-PRO TOOTH POLISHER Porta-Pro, Inc. JEQ Class I 1977-01-28
K770067 CYANOBOND Parker Laboratories, Inc. EMA Class II 1977-01-25
K770109 ENAMELITE ENAMEL COATING Lee Pharmaceuticals EBF Class II 1977-01-24
K770093 DENTAL BURS The S. S. White Co. EJL Class I 1977-01-24
K770091 EMERGENCY FAST-FIX DENTURE REPAIR KIT Mr. Clarence Hurst EBO Class II 1977-01-24
K770055 COMPOSITE RESTORATIVE MATERIAL, PRESTIGE Lee Pharmaceuticals EBF Class II 1977-01-14
K770064 FLUORIDE GEL DISPOSABLE TRAY Lorvic Corp. KMT Class I 1977-01-14

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