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Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
59
Latest Decision
1978-08-21

Clearances · page 125 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K781242 ALLOY, AMALGAM, DISP. CAPSULE Lee Pharmaceuticals EJJ Class II 1978-08-21
K781281 CEMENT, DENTAL/CAVITY LINER Star Dental Mfg. Co. EMA Class II 1978-08-21
K780966 LEE-ALLOY DISPOSABLE CAPSULES Lee Pharmaceuticals DZS Class I 1978-08-21
K781293 RESTORATIVE SYSTEM PROFILE The S. S. White Co. EBF Class II 1978-08-18
K781114 ULTRAMATE 990 Litton Dental Products EIA Class I 1978-08-14
K781060 MONOJECT ENDOSSEOUS DENTAL IMPLANT Sherwood Medical Industries DZE Class II 1978-08-14
K780997 AMALGAM ALLOY Syntex Corp. EJJ Class II 1978-07-27
K781045 A-33 DENTAL ALLOY Howmedica Corp. EJT Class II 1978-07-27
K781035 PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX Premier Dental Products Co. EMN Class I 1978-06-30
K781044 ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM Litton Dental Products ELC Class II 1978-06-30
K781018 DX TOOTHBRUSH Lever Brothers Company, Inc. EFW Class I 1978-06-30
K780814 SAFETY STOP NECKSTRAP Northwest Orthodontics, Inc. DYT Class I 1978-06-30
K780898 INSTANT CURE-1 Ultra-Light Corp. EBZ Class II 1978-06-30
K781034 PREMIER INLAY PLACER Premier Dental Products Co. EKI Class I 1978-06-30
K780619 PREFORMED TOOTH POSITIONER Tp Laboratories, Inc. KMY Class I 1978-06-28
K780967 LEE-ALLOY Lee Pharmaceuticals EJJ Class II 1978-06-22
K780811 DENTAL ABRASIVE DEVICE Cavitron Corp. EHL Class I 1978-06-22
K780808 PIEZOMATIC ULTRASONIC SCALER (SYSTEM S) Dental Ventures of America, Inc. ELC Class II 1978-06-22
K780796 ZYTRON Premier Dental Products Co. EBF Class II 1978-06-22
K780965 NEW RESTODENT Lee Pharmaceuticals EBF Class II 1978-06-22
K780786 DENTURE RELINE MATERIAL Dentsply Intl. EBI Class II 1978-06-14
K780864 DIAMOND STONES Venture Technology, Inc. DZP Class I 1978-06-14
K780804 HYGIENIC ANCHORINGS Hygienic Dental Mfg., Co., The ECI Class I 1978-06-14
K780832 ESTILUX MICROFILL Degussa Dental, Inc. EBF Class II 1978-06-14
K780833 ESTIC MICROFILL Degussa Dental, Inc. EBF Class II 1978-06-14
K780834 PREVI DENT PROPHYLAXIS MINT NDC Hoyt Laboratories EJR Class I 1978-06-02
K780778 RTV SILICONE HAND KNEADABLE PUTTY Crown Delta Corp. ELW Class II 1978-05-31
K780360 MASSAGER, GUM/SSAGE POWERED GUM Sunbeam Corp. JEQ Class I 1978-05-26
K780747 SNAP-WAY Northwest Orthodontics, Inc. DZB Class II 1978-05-26
K780722 ADVANCED DENTURE SYSTEM Advanced Marketing Research Co. EKO Class II 1978-05-26
K780752 PROPHYLAXIS ANGLE Young Dental Manufacturing Co. 1, LLC EGS Class I 1978-05-26
K780711 MICRO-RING Howmedica Corp. EGG Class I 1978-05-26
K780712 KERR DISCOVERY DISPOSABLE FLUORIDE TRAY Kerr Corporation (Danbury) KMT Class I 1978-05-17
K780701 DENTAL OFFICE ENVIRONMENT CONTROL UNIT Laminaire Corp. EHZ Class I 1978-05-16
K780746 HYGIENIC RUBBER DAM FRAME Hygienic Dental Mfg., Co., The EJE Class I 1978-05-12
K780743 CLAMP FORCEPS Hygienic Dental Mfg., Co., The EJG Class I 1978-05-12
K780744 BRINKER TISSUE RETRACTORS Hygienic Dental Mfg., Co., The EEF Class I 1978-05-12
K780745 RUBBER DAM Hygienic Dental Mfg., Co., The EIE Class I 1978-05-12
K780263 SHIELD Lorvic Corp. EJK Class II 1978-05-03
K780642 LITECAST SOLDER Williams Gold Refining Co., Inc. EJH Class II 1978-05-03
K780518 ULTRANOVAR, DENTAL U.V. CURING LAMP Demetron Research Corp. EBZ Class II 1978-04-28
K780678 IMPRESSION TRAY Rocky Mountain Orthodontics, Inc. EHY Class I 1978-04-28
K780646 AIR-PWOERED COLDRILL Medishield, Inc. EKX Class I 1978-04-28
K780483 FIBER OPTIC HANDPIECE Syntex Corp. EFB Class I 1978-04-28
K780641 DENTAL ROTARY CARBIDE BURS 76EJL Teledyne Densco EJL Class I 1978-04-21
K780560 DENTAL AMALGAMATOR L.D. Caulk Co. EFD Class I 1978-04-21
K780528 PREMIER CARVERS, STYLE #21C & 21D Premier Dental Products Co. EKH Class I 1978-04-19
K780469 PANORAMIC X-RAY, DENTAL Den-Tal-Ez Mfg Co., Inc. EHD Class II 1978-04-10
K780334 ADHESIVE, BRACKET AND CONDITIONER RESIN Rocky Mountain Orthodontics, Inc. DYH Class II 1978-03-28
K780400 DEN-Z-ORB Nice-Pak Products, Inc. KHR Class I 1978-03-27
K780239 BRACKET, METAL REINFORCED PLASTIC Ormco Corp. DYW Class II 1978-03-15
K780170 ORTHODONTIC BRACKET PADS Rocky Mountain Orthodontics, Inc. EJF Class I 1978-03-15
K780164 RTV DENTAL SILICONE Tydont, Inc. ELW Class II 1978-03-15
K780384 IMPROVED DYCAL L.D. Caulk Co. EJK Class II 1978-03-15
K780217 ANTERIORS AND POSTERIORS, PLASTIC Dentsply Intl. ELM Class II 1978-03-15
K780376 MINIDENTOFLEX NEW POLISHING SYSTEM Cavitron Corp. EHL Class I 1978-03-14
K780090 DENTAL ALLOY Krupp International, Inc. EJH Class II 1978-03-14
K780377 PINIDENTOFLEX DENTAL POLISHER Cavitron Corp. EHL Class I 1978-03-14
K780254 DENTURE CLEANSER & TOOTHPASTE IN ONE Richardson Merrel, Inc. JER Class I 1978-03-09
K780301 CAULK TYLOK L.D. Caulk Co. EMA Class II 1978-02-28
K780174 ORABRITE Norcliff Thayer, Inc. JER Class I 1978-02-23
K780213 HANDPIECE, LIFT, ENDO Kerr Corporation (Danbury) EGS Class I 1978-02-17
K780199 PROPHY ANGLES, R&R Ransom and Randolph EGS Class I 1978-02-16
K780198 PROPHY CUPS, R&R Ransom and Randolph EHK Class I 1978-02-16
K780205 ORTHODONTIC BUCCAL TUBE Rocky Mountain Orthodontics, Inc. DZD Class I 1978-02-16
K780211 4-IN-1 DISP. CROWN & BRIDGE TRAY Kerr Corporation (Danbury) EHY Class I 1978-02-16
K772244 ILLUMINATED DENTAL HANDPIECE Litton Dental Products EFB Class I 1978-01-20
K780038 DENTAL HANDPIECE Lares Manufacturing Co., Inc. EFB Class I 1978-01-20
K772351 DENTAL LIGHT Chemetron Dental Products EAZ Class I 1978-01-17
K780028 ORTHODONTIC. PLASTIC BRACKET PRIMER 3M Company DYH Class II 1978-01-17
K771974 SOLVENEX I-0 Den-Mat Corp. KZP Class II 1978-01-12
K771114 NEUTROCIM Septodont, Inc. EMA Class II 1978-01-04
K772304 DENTAL IMPLANT, CARBON COATED METAL General Atomic Co. DZE Class II 1978-01-03
K772316 MATRIX STRIP, DEAD-SOFT Den-Mat Corp. DZN Class I 1978-01-03
K772314 WEDGES, RETAINING, MATRIX Den-Mat Corp. DZN Class I 1978-01-03
K772279 FOTOFILL DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. EBF Class II 1978-01-03
K772278 FOTOFILL ACTIVATOR LIGHT Johnson & Johnson Professionals, Inc. EBZ Class II 1978-01-03
K772256 CROWN & BRIDGE ALLOY Johnson & Johnson Professionals, Inc. EJH Class II 1978-01-03
K772300 DENTAL CHAIR, VANGUARD Ritter Co. KLC Class I 1978-01-03
K772315 KWIKAP Den-Mat Corp. EMB Class I 1978-01-03
K772126 TEMP. BRIDGE, POSTERIOR 3-UNIT Lee Pharmaceuticals DYH Class II 1978-01-03
K772211 TEMP. ACRYLIC Lactong Corp. EBG Class II 1977-12-22
K772184 X-RAY SYSTEM FOR DENTAL APPLICATION General Electric Co. EAP Class II 1977-12-22
K772164 PANORAMIC X-RAY SYSTEM MODEL A Sybron Corp. EHD Class II 1977-12-02
K771921 HYDRON ROOT CANAL FILLING SYSTEM National Patent Development Corp. KIF Class II 1977-11-15
K772087 ULTRASONIC DENTURE CLEANER Clairol, Inc. EFT Class I 1977-11-14
K771886 ACCU-PAQUE Williams Gold Refining Co., Inc. EIH Class II 1977-11-14
K771887 ACCU-STAIN Williams Gold Refining Co., Inc. EIH Class II 1977-11-14
K771973 GINGITRACT Den-Mat Corp. EIG Class I 1977-11-07
K771908 ISO-SHIELD SALIVA ABSORBERS 3M Company KHR Class I 1977-11-07
K771938 ALGINATE IMPRESSION MATERIAL The S. S. White Co. ELW Class II 1977-11-02
K771852 NIMETIC POLISHING PASTE Espe GmbH (Us) EJR Class I 1977-11-02
K771873 VISION SERIES DENTAL CHAIR Chayes Virginia, Inc. KLC Class I 1977-10-25
K771883 REPLICA ACID-ETCH Hoyt Laboratories DYH Class II 1977-10-20
K771858 EXPAND. RETENTION ENDOSSEOUS IMPLANT A.L. Miller, Inc. DZE Class II 1977-10-20
K771882 REPLICA DENTAL COMPOSITE-RADIOPAQUE Hoyt Laboratories EBF Class II 1977-10-20
K771890 PERCEPTION SERIES DELIVERY SYS. Chayes Virginia, Inc. EIA Class I 1977-10-20
K771889 UNIOLITE Espe Dental Products EBZ Class II 1977-10-20
K771901 CAPMIX Espe Dental Products EFD Class I 1977-10-20
K771880 REPLICA DENTAL COMPOSIT Hoyt Laboratories EBF Class II 1977-10-20

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