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Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
58
Latest Decision
1983-07-28

Clearances · page 118 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K831484 COMPOSI-GLAZE Denpac Corp. EBF Class II 1983-07-28
K831483 SAVE-A-BAKE PORCELAIN POLISH Denpac Corp. EIH Class II 1983-07-28
K831293 SOLARCRYL CUSTOM TRAY MATERIAL Solar Dental Co., Inc. EBH Class I 1983-07-26
K830764 FR ROOT CANAL SEALER Shizai Corp. EKA Class I 1983-07-26
K831495 CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO Scientific Pharmaceuticals, Inc. DYH Class II 1983-07-18
K822411 SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 Western Advanced Technology, Inc. EIB Class I 1983-07-12
K831749 ENDODONTIC BROACH(76EKN) BARBED BROACH Union Branch EKW Class I 1983-07-12
K831748 ENDODONTIC ROOT CANAL PLUGGER FINGER- Union Branch EKR Class I 1983-07-12
K831321 GUM MACHINE The Gum Machine Co. EFS Class I 1983-07-07
K831559 CERTAIN *DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. EBF Class II 1983-06-30
K831493 DENTURE ADHESIVE SEALS Johnson & Johnson Professionals, Inc. KOT Class I 1983-06-30
K831647 DENTURE RELINING, REPAIR/REBASING RESIN Dentsply Intl. EBI Class II 1983-06-30
K831575 NU-CAP CALCIUM HYDROX. PULP CAPPING Coe Laboratories, Inc. EJK Class II 1983-06-30
K831380 DELTON LIGHT CURING PIT & FISSURE Johnson & Johnson Professionals, Inc. EBC Class II 1983-06-30
K831098 DOMINION Unitek Corp. EJT Class II 1983-06-16
K831097 CONCERTO Unitek Corp. EJS Class II 1983-06-15
K831096 STROMA II Unitek Corp. EJS Class II 1983-06-15
K831269 VINYLAC PRESS-PACK DENTURE RESIN Astron Dental Corp. EBI Class II 1983-06-08
K831136 DOUBLE BOW TOOTH SEPARATOR Almore Intl., Inc. JEP Class I 1983-06-08
K831280 NEY-ORO 60 Deringer-Ney, Inc. EJT Class II 1983-06-08
K830441 DIFF 4 SYSTEM Coulter Electronics, Inc. EKZ Class II 1983-05-16
K831214 DELTA TEETH Dentsply Intl. ELM Class II 1983-05-09
K830955 DENTAL CERAMIC FOR FABRICATION OF CROWN Dentsply Intl. EIH Class II 1983-05-09
K830439 DENTA A-33 Denta, Inc. EGG Class I 1983-05-09
K831037 AIR BURBINE HANDPIECE-DENTAL SCALING Taco Dental, Inc. ELB Class II 1983-05-09
K830513 FIRST TM Phasealloy EBF Class II 1983-05-09
K831265 DENTOLOCK DENTURE ADHESIVE CREAM Solar Dental Co., Inc. KOQ Class I 1983-05-09
K831254 DENTAL FLOSS HOLDER Sewon Industry JES Class I 1983-05-09
K830113 SEPTOPACK North Pacific Dental, Inc. EMA Class II 1983-05-09
K830440 DENTA PLAST Denta, Inc. EMA Class II 1983-04-28
K830773 MARKLEY THREADED WIRE Almore Intl., Inc. EBL Class I 1983-04-28
K830775 FACEBOW FOR BALANCE ARTICULATOR Almore Intl., Inc. KCR Class I 1983-04-28
K830776 MICROFIL CONTOURING INSTRUMENTS Almore Intl., Inc. EIY Class I 1983-04-28
K830553 DENTAL PORCELAIN POWDER Dentsply Intl. EIH Class II 1983-04-06
K830044 ODONTIC CENTRIC(BITE) REGIST. PASTE Wallace A. Erickson & Co. ELW Class II 1983-04-06
K830777 ELECTRIC MOUTH MIRROR Almore Intl., Inc. EAX Class I 1983-04-06
K830304 REPLAM HYDROXYAPATITE Replam Corp. LYC Class II 1983-04-06
K822095 HERPES-IHA KIT Hillcrest Biologicals KLC Class I 1983-04-05
K830524 HENKE JECT PRESSURE SYRINGE Smith & Nephew, Mpl Division EJI Class II 1983-03-24
K830414 TITANALOY SUBMERSIBLE IMPLANT SYSTEM Boehringer/Miter, Inc. DZE Class II 1983-03-24
K830380 MICRODAPT DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. EBF Class II 1983-03-17
K830491 JOHNSON & JOHNSON OPAQUE COLOR MODIFI Johnson & Johnson Professionals, Inc. EBE Class II 1983-03-17
K830387 MICRODAPT DENTAL RESTORATIVE BONDING Johnson & Johnson Professionals, Inc. KLE Class II 1983-03-17
K830442 PRISMA-FINE Dentsply Intl. EBF Class II 1983-03-17
K830114 GUTTA PERCHA POINTS North Pacific Dental, Inc. EKM Class I 1983-03-01
K830105 VITATHYL North Pacific Dental, Inc. EAT Class II 1983-03-01
K830115 PAPER POINTS North Pacific Dental, Inc. EKM Class I 1983-03-01
K830117 ENDOMET North Pacific Dental, Inc. EMA Class II 1983-03-01
K830187 FOCUS FLUID Hematology Marketing Assoc. EIF Class I 1983-03-01
K830109 CIMPAT North Pacific Dental, Inc. EMR Class I 1983-03-01
K830175 STERILE COTTON ROLLS #3, 1 1/2 Veratex Corp. EFN Class I 1983-02-18
K830116 SULCARINGS North Pacific Dental, Inc. EIF Class I 1983-02-18
K830112 HYDROL North Pacific Dental, Inc. EJK Class II 1983-02-18
K830107 SELFAST North Pacific Dental, Inc. EMA Class II 1983-02-18
K830225 THE TOOTHPIK Fred M. Davis JES Class I 1983-02-18
K830083 SHUR GEL Columbus Dental Mfg. Co. ELW Class II 1983-02-07
K823935 MICRO JOIN, CROWN & BRIDGE ADHESIVE Sci-Pharm, Inc. EMA Class II 1983-02-07
K823795 EVERBOND GLASS IONOMER CEMENT Sybron Corp. EMA Class II 1983-01-26
K830042 E-Z JECTOR Innovators, Inc. EJI Class II 1983-01-26
K823913 SOFT GRIP UNI-HANDLE Treace Medical, Inc. EJB Class I 1983-01-26
K823928 TOOTH CONDITIONER Dentsply Intl. DYH Class II 1983-01-26
K823914 EXPLORER TIP Treace Medical, Inc. EKB Class I 1983-01-21
K823409 HELIOSIT-ORTHODONTIC Vivadent (Usa), Inc. DYH Class II 1983-01-21
K823486 TOUCH-N-HEAT MODEL 5001 Analytic Technology EKM Class I 1983-01-18
K823568 POLY-TONE DENTURE BASE RESIN General Dental Products, Inc. EBI Class II 1983-01-12
K823851 ORTHODAPTIC* BONDING ADHESIVE Johnson & Johnson Professionals, Inc. DYH Class II 1983-01-09
K823676 DISC NEEDLE SET #TX-8220 Today'S Machining & Design, Inc. EMI Class I 1983-01-09
K823684 FILE TYPE K ENDODONTIC United Dental Mfg., Inc. EKS Class I 1982-12-28
K823510 CURAY ANTERIOR/POSTERIOR RESTORATIVE Scientific Pharmaceuticals, Inc. EBF Class II 1982-12-28
K823536 INTRALIG Miltex Instrument Co. EJI Class II 1982-12-28
K823744 PORCELAIN ARTIFICIAL TEETH Dentsply Intl. ELL Class II 1982-12-28
K823686 REAMER TYPE K ENDODONTIC United Dental Mfg., Inc. EKP Class I 1982-12-28
K823732 CBM, CORE BUILD-UP MATERIAL Scientific Pharmaceuticals, Inc. EBD Class II 1982-12-28
K823685 FILE TYPE H (HEDSTROEM) ENDODONTIC United Dental Mfg., Inc. EKS Class I 1982-12-28
K823489 ENDODONTIC BROACH-BARBED BROACH Union Broach, Div. Moyco Industries, Inc. EKW Class I 1982-12-15
K823377 CERA 8 Cer-Met, Inc. EIH Class II 1982-12-03
K823230 STERILE WATER SYSTEM Syntex Dental Products, Inc. EIA Class I 1982-12-03
K823378 CERA COLOR Cer-Met, Inc. EIH Class II 1982-12-03
K823316 DENTAL INSTRUMENTS - FILES Miltex, Inc. EKS Class I 1982-11-24
K823319 DENTAL INSTRUMENTS - SCALERS Miltex, Inc. EMS Class I 1982-11-24
K823305 DENTO SPRAY ORAL IRRIGATOR Neo-Life Co. of America EFS Class I 1982-11-24
K823321 DENTAL INSTRUMENTS - CARVER Miltex, Inc. EKH Class I 1982-11-24
K823318 DENTAL INSTRUMENTS - EXCAVATORS Miltex, Inc. EKS Class I 1982-11-24
K823315 DENTAL INSTRUMENTS - KNIVES Miltex, Inc. EJZ Class I 1982-11-24
K823325 DENTAL INSTRUMENTS - SURGICAL FORCEPS Miltex, Inc. EMG Class I 1982-11-24
K823326 DENTAL INSTRUMENTS - CUTTING INSTRUMENT Miltex, Inc. ELA Class I 1982-11-24
K823320 DENTAL INSTRUMENTS - BONE CHISELS Miltex, Inc. EML Class I 1982-11-24
K823314 DENTAL INSTRUMENTS Miltex, Inc. EJL Class I 1982-11-24
K823323 DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS Miltex, Inc. EIY Class I 1982-11-24
K823324 DENTAL INSTRUMENTS - PROBES Miltex, Inc. EIX Class I 1982-11-24
K823322 DENTAL INSTRUMENTS - PLUGGERS Miltex, Inc. EKG Class I 1982-11-24
K823280 DISTAFLEX Duradent Corp. EGG Class I 1982-11-22
K823185 GAMMA LIGHT CURING DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. EBF Class II 1982-11-22
K823180 SA-21 DENTAL UNIT Ritter Co. EIA Class I 1982-11-22
K823278 DENTAL FLOSS TIP Sanderson Creative Products Co. JES Class I 1982-11-22
K823133 AIR FLOW I Healthco, Inc. EIA Class I 1982-11-17
K823134 AIR FLOW II Healthco, Inc. ELC Class II 1982-11-17
K823099 RX MIDACAST Bauer, Cheng & Associates, Inc. EJT Class II 1982-11-10
K823098 REX-CAPS Bauer, Cheng & Associates, Inc. EJJ Class II 1982-11-10
K823100 RX 91 Bauer, Cheng & Associates, Inc. EJS Class II 1982-11-10

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