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Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
40
Latest Decision
1989-04-17

Clearances · page 106 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K882572 DOCTOR KOLYNOS TOOTHBRUSH Whitehall Laboratories, Inc. EFW Class I 1989-04-17
K891615 SURGICAL DRILLS Implant Innovations International, Inc. DZE Class II 1989-04-17
K891354 ORTHODONTIC COTTON ROLL HOLDERS American Orthodontics KHR Class I 1989-04-17
K891618 TITANIUM FORCEPS Implant Innovations International, Inc. DZE Class II 1989-04-17
K884166 DICOR CERAMIC INLAY - NEW TECHNIC Dentsply Intl. ELW Class II 1989-04-17
K890656 LIP BUMPER American Orthodontics EJF Class I 1989-04-17
K891119 T.R.S.: TOOTH REPLACEMENT SYSTEM Health Technology of America, Inc. EGG Class I 1989-04-17
K891390 GK ALLOY China Link, Inc. EJJ Class II 1989-04-17
K890623 FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT Macrochem Corp. EMA Class II 1989-04-17
K890608 FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT Macrochem Corp. EMA Class II 1989-04-17
K890668 CLEAN DENT Lincoln Park Dental Laboratory EFT Class I 1989-04-17
K890829 UNIFAST LC G-C Intl. Corp. EBG Class II 1989-04-17
K882303 H&M ANTI-SNORING DEVICE Hays & Meade, Inc. LRK Class II 1989-04-14
K891516 C-89 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-14
K891484 ORTHODONTIC WRAP-AROUND HAWLEY RETAINER American Orthodontics EJF Class I 1989-04-14
K891530 M-77 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-14
K884937 BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING Grass-Telefactor Product Group EEG Class I 1989-04-14
K884533 SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM Block Drug Company, Inc. KLE Class II 1989-04-12
K891186 REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT Benn Research , Ltd. EHA Class I 1989-04-12
K891520 C-87 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891534 M-75 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891525 M-46 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891532 M-70 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891531 M-50 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891519 C-86 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891533 M-74 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891521 M-1 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891535 P-C PALLADIUM BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891528 M-65 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891522 M-4 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891523 M-20 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891529 M-W SILVER PALLADIUM BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891514 C-5 PALLADIUM BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891524 M-40 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891517 C-63 GOLD BAE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891518 C-76 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891527 M-60 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-12
K891515 C-52 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-07
K891526 M-56 GOLD BASE DENTAL ALLOY Macdonald Metals and Ceramics EJT Class II 1989-04-07
K891592 ORTHODONTIC ARCH AND SURGICAL HOOKS American Orthodontics EJF Class I 1989-04-07
K884308 MANDIBLE MANIPULATOR Leonard Medical, Inc. EKJ Class I 1989-03-31
K891372 ORTHODONTIC PLASTIC BRACKET American Orthodontics DYW Class II 1989-03-31
K890123 CLEARFIL CR INLAY Kuraray Co. EBF Class II 1989-03-31
K891328 PREFORMED TEMPLATE FOR TOOTH POSITIONER American Orthodontics KMY Class I 1989-03-31
K890140 PHOSPHORIC-ACID ETCHING GEL Centrix, Inc. EBF Class II 1989-03-29
K890290 BRACE (ORAFIX SPECIAL) Norcliff Thayer, Inc. ECB Class I 1989-03-29
K890494 FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS Macrochem Corp. EBC Class II 1989-03-29
K890667 RUBBER DAM Cost Rite Health Products, Inc. EIE Class I 1989-03-29
K890581 THE CLARK LIP SHIELD American Orthodontics EJF Class I 1989-03-17
K890812 HEADS TRUE BRUSH Mcs Trading Co. EFW Class I 1989-03-17
K885189 MASSAGING PICK FOR ORAL HYGIENE Dentek Corp. JET Class I 1989-03-17
K883842 DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI. Dentsply Intl. ELW Class II 1989-03-17
K884222 CURING LIGHT COVER Steri-Shield Products, Inc. EBZ Class II 1989-03-17
K884220 AIR WATER SYRINGE TIP SHIELD Steri-Shield Products, Inc. EFS Class I 1989-03-17
K884223 DENTAL LAMP HANDLE COVER Steri-Shield Products, Inc. EAZ Class I 1989-03-17
K884221 ULTRASONIC SCALER COVER Steri-Shield Products, Inc. ELC Class II 1989-03-17
K890811 RX APF (CASTING ALLOY) Jeneric/Pentron, Inc. EJS Class II 1989-03-17
K884219 BRACKET TABLE ARM COVER Steri-Shield Products, Inc. EIA Class I 1989-03-17
K885299 SANI-SLEEVE DRAPE FOR DENTAL USE Nieusma R & D, Inc. EIA Class I 1989-03-16
K890910 PLAKOF Ximex, Ltd. JET Class I 1989-03-16
K890493 FLORIDA PROBE PERIODONTAL PROBE Florida Probe Corp. EIL Class I 1989-03-13
K884140 ROS-TR SYSTEM Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn DZE Class II 1989-03-13
K890145 20/20 ORTHODONTIC CERAMIC BRACKET American Orthodontics EJF Class I 1989-03-13
K890734 DRY TIPS Microcopy, Div. Neo-Flo, Inc. KHR Class I 1989-03-10
K890529 ALASTIGARD Unitek Corp. EJF Class I 1989-03-09
K890569 NEYORO 65CF Deringer-Ney, Inc. EJT Class II 1989-03-09
K890568 ULTIMA LITE Deringer-Ney, Inc. EJT Class II 1989-03-09
K884740 EURO-MED LIGHT TOUCH BIOPSY PUNCH Buckman Co., Inc. EME Class I 1989-03-06
K885007 CIMPAT S TEMPORARY DENTAL CEMENT Specialites Septodont EMA Class II 1989-03-01
K884999 HOLD-FAST DENTURE ADHESIVE Iodent, Co. KOL Class I 1989-02-24
K884949 VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER Ortho Source EJK Class II 1989-02-23
K890333 ALBUMIN REAGENT Alpkem Corp. EIX Class I 1989-02-17
K890357 DENTAL IMPRESSION SYINGE Innotek Dental Corp. EKJ Class I 1989-02-13
K884918 PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER Parkell KLE Class II 1989-02-13
K885075 ABIOMED PERIOTEMP(TM) PROBE Abiomed, Inc. EIL Class I 1989-02-13
K885233 NOVA DIAMOND Microcopy, Div. Neo-Flo, Inc. DZP Class I 1989-02-13
K885302 GOLD/PALLADIUM BASED DENTAL ALLOY Jelenko Co. EJT Class II 1989-02-13
K882417 POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT Milton Hodosh, M.D. EMA Class II 1989-02-13
K885010 TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING Coe Laboratories, Inc. KLE Class II 1989-02-13
K890464 ZENITH 40% PHOSPHORIC ACID GEL Foremost Dental Mfg., Inc. EBC Class II 1989-02-13
K884845 STERI-OSS Denar Corp. DZE Class II 1989-02-10
K884830 DENTAL CHAIR F1 Fimet OY KLC Class I 1989-02-10
K890064 DENTAL SYRINGE APPLICATION TIP Centrix, Inc. EKJ Class I 1989-02-10
K884828 HANDIDAM Aseptico, Inc. EIE Class I 1989-02-03
K884865 PERMASEAL AND DENTURE SEAL American Mfg., Inc. EBI Class II 1989-01-30
K890255 BONE RONGEUR, SINGLE-ACTION Kinetic Medical Products EMH Class I 1989-01-27
K890256 BONE RONGEUR, DOUBLE-ACTION Kinetic Medical Products EMH Class I 1989-01-27
K884588 HELIOMOLAR(R) DENTAL RESTORATIVE Williams Dental Co., Inc. EBF Class II 1989-01-27
K884751 DANSU PERMANENT CHAIR SOFT LINER American Mfg., Inc. EBI Class II 1989-01-27
K890243 DRESSING FORCEPS Kinetic Medical Products EFL Class I 1989-01-27
K885219 DENTAL DRESSING PLIERS Wen Hao, Inc. EKJ Class I 1989-01-19
K885218 DISCARD DENTAL MIRROR Wen Hao, Inc. EKJ Class I 1989-01-19
K885217 DISCARD DENTAL EXPLORER Wen Hao, Inc. EKJ Class I 1989-01-19
K884752 KETAC-GLAZE Espe GmbH (Us) KLE Class II 1989-01-19
K884653 RACESTYPTINE Specialites Septodont EKJ Class I 1989-01-19
K883373 STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT Denar Corp. DZE Class II 1989-01-13
K885067 4060 HA PARTICLES Bio-Interfaces, Inc. LYC Class II 1989-01-11
K885040 DENTAL MIRROR RETRACTOR Nu-Lite Retractor, Inc. EKJ Class I 1989-01-10
K885162 BENDA BRUSH Centrix, Inc. EKJ Class I 1989-01-10
K884515 BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED Gatewood and Associates, Ltd. EKJ Class I 1989-01-10

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