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Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
55
Latest Decision
1979-09-04

Clearances · page 124 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K791014 DENTAL XERORADIOGRAPHY Xerox Medical Systems EAP Class II 1979-09-04
K791491 BIOLITE CARBON COATED DENTAL IMPLANT Carbomedics, Inc. DZE Class II 1979-09-04
K791133 ABCOR CARIES DETECTOR MONITOR Abcor, Inc. LFC Class II 1979-08-28
K791237 PYROLITE CARBON ENDOSSEOUS DENTAL IMPL Carbomedics, Inc. DZE Class II 1979-08-28
K790589 DENTURE-TIGHT Den-Mat Corp. EBP Class II 1979-08-10
K791078 ANTERIOR/POSTERIOR RESTORATIVE, BOND Scientific Pharmaceuticals, Inc. EBD Class II 1979-08-10
K791067 SCI-PHARM PAINT-ON RESTORATIVE Scientific Pharmaceuticals, Inc. EBD Class II 1979-08-10
K791005 CHEMODENT CERAMIC METAL Chemodent Dental Laboratory EJS Class II 1979-08-10
K791132 SCI-PHARM ORTHODONTIC ADHESIVE Scientific Pharmaceuticals, Inc. DYH Class II 1979-08-10
K790806 PORCELIT Harry J. Bosworth Co. EBA Class I 1979-08-03
K790935 DELTON* PIT AND FISSURE SEALENT Johnson & Johnson Professionals, Inc. EBC Class II 1979-08-03
K790807 METALIT Harry J. Bosworth Co. EBA Class I 1979-08-03
K791019 MCSPADDEN CONDENSOR Techdent, Inc. EKR Class I 1979-08-03
K790339 CONCEPT II Richardson Merrel, Inc. EBE Class II 1979-07-17
K790788 FISSURE SEALER AND BONDING AGENT Scientific Pharmaceuticals, Inc. EBC Class II 1979-07-06
K790789 COMPOSITE RESTORATIVE, PASTE/PASTE TYPE Scientific Pharmaceuticals, Inc. EBF Class II 1979-07-06
K790822 ANTERIOR/POSTERIOR RESTORATIVE LIQUID Scientific Pharmaceuticals, Inc. EBF Class II 1979-07-06
K790963 PAINT-ON RESTORATIVE, LIGHT CURED Scientific Pharmaceuticals, Inc. EBF Class II 1979-07-06
K790962 SEAL & BOND DIRECT BONDING ORTHODONTIC Scientific Pharmaceuticals, Inc. DYH Class II 1979-07-06
K790722 PROPHYLAXIS ANGLE Young Dental Manufacturing Co. 1, LLC EGS Class I 1979-06-15
K790595 DENTAL ALGINATE IMPRESSION MATERIAL Wallace A. Erickson & Co. ELW Class II 1979-06-15
K790723 PROPHYLAXIS CUPS AND POLISHERS Young Dental Manufacturing Co. 1, LLC EHK Class I 1979-06-15
K790866 14 KARAT CASTING GOLD Williams Gold Refining Co., Inc. EJT Class II 1979-06-15
K790897 QUAD IV CUSTOM IMPRESSION TRAY Sted, Inc. EBH Class I 1979-06-15
K790592 IMPRESSION MATERIAL, RUBBER Wallace A. Erickson & Co. ELW Class II 1979-06-15
K790593 DENTAL CEMENT, ZINC PHOSPHATE Wallace A. Erickson & Co. EMA Class II 1979-06-15
K790594 DENTAL COMPOSITE RESTORATIVE MATERIAL Wallace A. Erickson & Co. EBF Class II 1979-06-15
K790596 ENAMEL BOND SYSTEM Wallace A. Erickson & Co. EBC Class II 1979-06-15
K790874 AMALCAP-NON-GAMMA-2 Vivadent (Usa), Inc. EJJ Class II 1979-06-05
K790799 PULPTESTER MODEL 2001 Analytic Technology EAT Class II 1979-05-31
K790843 SNAP-WAY Northwest Orthodontics, Inc. DZB Class II 1979-05-31
K790601 DENTAL HANDPIECE Venture Technology, Inc. EFB Class I 1979-05-31
K790600 HOWMEDICA STRIP CROWN Howmedica Corp. DZN Class I 1979-05-21
K790598 RUWA FINISHING STRIPS Howmedica Corp. EHM Class I 1979-05-21
K790599 RUWA MATRIX STRIPS Howmedica Corp. DZN Class I 1979-05-21
K790633 ACCOR MATRIX Accor, Inc. DZN Class I 1979-05-17
K790586 CHEMBOND L.D. Caulk Co. EMA Class II 1979-05-16
K790585 FINESSE L.D. Caulk Co. EBF Class II 1979-05-16
K790588 ASSAY REAGENTS, LSA 290 Kallestad Laboratories, Inc. JEW Class I 1979-05-15
K790322 OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 Applied Medical Research EBW Class I 1979-05-14
K790641 GDC-685 Deringer-Ney, Inc. EJS Class II 1979-05-01
K790640 HOWMEDICA BRASS CENTER DISC E.C. Moore Co. EHJ Class I 1979-05-01
K790832 KETAC APPLIC-CAPSULES Espe GmbH (Us) EMA Class II 1979-04-30
K790833 VISIO-BOND Espe GmbH (Us) KLE Class II 1979-04-30
K790193 MIZZY SYRIJET MARK IV Mizzy, Inc. EGM Class II 1979-04-23
K790448 EASYFIL General Refineries, Inc. EJJ Class II 1979-04-11
K790439 CONTACT RESIN Vivadent (Usa), Inc. EBF Class II 1979-04-10
K790290 NEY EQUI-HINGE Deringer-Ney, Inc. ECG Class I 1979-04-10
K790414 DEVELOPMENT NO. 647 Deringer-Ney, Inc. EJT Class II 1979-04-10
K790378 REYNOLDS BLEACHING PROCESS Reynolds Laboratories EEG Class I 1979-04-10
K790438 COLORANT Vivadent (Usa), Inc. EBD Class II 1979-04-10
K782165 PHASEAFILL Phasealloy EBF Class II 1979-03-21
K790325 REPRODENT Premier Dental Products Co. EBI Class II 1979-03-02
K790078 BAR & RIDER, SCREWS, TUBES Eurodent, Inc. ECG Class I 1979-02-27
K790006 GDC-591 Deringer-Ney, Inc. EJT Class II 1979-02-27
K782133 ODONTOSON 3 Mdt Corp., Inc. ELC Class II 1979-02-27
K790113 MIDWEST 1000 Midwest EFB Class I 1979-02-26
K790112 MOBILE UNITS, I,II,III,IV Dentsply Intl. EIA Class I 1979-02-26
K790096 SALIVAN PARAEIGHT TOUGHNESS Den-Mat Corp. EJS Class II 1979-02-26
K782153 IMPRESSION TRAY, MDDS CUSTOM Chayet and Sonnenrich, P.C. EBH Class I 1979-02-26
K790097 SALIVAN & SALIVAN BROWN Den-Mat Corp. EJS Class II 1979-02-26
K790127 CEMENT, CERAMCO Johnson & Johnson Professionals, Inc. EMA Class II 1979-02-26
K782139 ZYLOX Premier Dental Products Co. ELW Class II 1979-02-21
K782080 VENEER SYSTEM, MOSTIQUE LAMINATE Caulk Co., Div. Dentsply KLE Class II 1979-01-26
K782068 MVS UNIT, MODEL SEU-8 AND DEU-8, 80 Dentsply Intl. EHZ Class I 1979-01-26
K782007 ROTARY SCALER Star Dental Mfg. Co. ELB Class II 1979-01-03
K781878 LIGHT, INSIDE Midwest EAY Class I 1978-12-29
K781788 GOLD, 24 KARAT CASTING Williams Gold Refining Co., Inc. EJT Class II 1978-12-28
K781882 MODULAT DENTAL SYSTEMS Vacudent Sales Corp. EIA Class I 1978-12-28
K781974 IMPLANT DRIVERS AND TIPS Miter, Inc. DZJ Class II 1978-12-28
K781935 NU-GLAZE Deringer-Ney, Inc. ELL Class II 1978-12-20
K781787 ISOPLAST Vivadent (Usa), Inc. EBF Class II 1978-12-20
K781977 APPLICATOR, LEE IMPRESSION Lee Pharmaceuticals EID Class I 1978-12-20
K781688 LINER, CAVITY CALCIUM HYDROXIDE Kerr Corporation (Danbury) EJK Class II 1978-12-20
K781777 ABRASIVE WHEELS Dentsply Intl. EJQ Class I 1978-12-20
K781962 DIJI-DENT J&J Technologies, Inc. EFW Class I 1978-12-20
K781919 PLAQUE DETECTION SYSTEM Clairol, Inc. NYH Class II 1978-12-04
K781687 AUROFIL Wallace A. Erickson & Co. EBF Class II 1978-12-04
K781594 DENTAL WARM WATER IRRIGATING SYSTEM Rama Corp. ECB Class I 1978-12-04
K781675 X-RAY COLLIMATOR General X-Ray, Inc. EHB Class I 1978-12-04
K781630 GE-700 INTRA ORAL X-RAY SYSTEM General Electric Co. EAP Class II 1978-12-04
K781592 SURGICAL ASPIRATOR TIPS Henry Schein, Inc. DYN Class I 1978-12-04
K781545 AIR POWERED DENTAL HANDPIECE Promident Mfg., Ltd. EFB Class I 1978-11-15
K781689 REFLECT IMPRESSION MATERIAL Kerr Corporation (Danbury) ELW Class II 1978-11-15
K781779 SANI-DENT DENTURE CLEANER Sandi-Dent JER Class I 1978-11-08
K781580 PERFIT DENTAL RESTORATIVE COMPOSITE Locite Corp. EBF Class II 1978-10-11
K781520 RUBBER DAM HOLDER Young Dental Manufacturing Co. 1, LLC EJE Class I 1978-10-10
K781605 R&R ABSORBENT POINTS Ransom and Randolph EKN Class I 1978-10-10
K781098 BRUSH, APPLICATOR 3M Company KXR Class I 1978-09-29
K781486 STERI-VAC POWER UNITS Cpac, Inc. EHZ Class I 1978-09-27
K781488 MVS-MODEL SEU-6, DEU-6 Dentsply Intl. EHZ Class I 1978-09-27
K781243 MERCURY DISP. CAPSULE Lee Pharmaceuticals DZS Class I 1978-09-20
K781288 DENTAL X-RAY UNIT HELIODENT 70 Siemens Corp. EHD Class II 1978-09-11
K781287 DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH Siemens Corp. EAG Class II 1978-09-11
K781286 DENTAL X-RAY UNIT Siemens Corp. EHD Class II 1978-09-11
K781151 REPROSIL Dentsply Intl. ELW Class II 1978-08-31
K781345 ULTRAFILL- ULTRABOUND Demetron Research Corp. EBD Class II 1978-08-31
K781083 DENTAL SILICONE IMPRESSION MATERIAL Crown Delta Corp. ELW Class II 1978-08-31
K781244 TEMP. CROWN MSTERIAL FOR TEETH Den-Mat Corp. EBG Class II 1978-08-31
K781169 IMAGE Deringer-Ney, Inc. EJT Class II 1978-08-31

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