meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
48
Latest Decision
1984-08-17

Clearances · page 116 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K842846 SEWON DENTAL FLOSS FOLDER Sewon Industry JES Class I 1984-08-17
K842403 LUSTER, DENTAL POLISHING PASTE Scientific Pharmaceuticals, Inc. EJR Class I 1984-08-17
K842163 RIDGEMATRIX 20/40 MESH, PERIOMATRIX Orthomatrix, Inc. LYC Class II 1984-08-09
K841201 POROUS HYDROXYAPATITE BG200 Interpore Intl. LYC Class II 1984-08-03
K842581 CAVI-MED Cooper Lasersonics, Inc. ELC Class II 1984-08-03
K842551 BASE METAL ALLOY Dentsply Intl. EJH Class II 1984-08-02
K842463 GX CEPH Gendex Corp. EAG Class II 1984-08-02
K842515 SURGICAL HEADLIGHT Good-Lite Co. EBA Class I 1984-08-02
K842208 NATURA-TONE OR LUXOPAL CL ACRYLIC Parexel Intl. Corp. ELM Class II 1984-07-31
K842377 MS NONPRECIOUS CROWN & BRIDGE ALLOY Dental Ventures of America, Inc. EJH Class II 1984-07-31
K842273 CROWN INDEX TRAY Di-Equi Dental Products EHY Class I 1984-07-31
K842274 F-G-P TRAY Di-Equi Dental Products EHY Class I 1984-07-31
K842358 ISOLIGHT Planmeca USA, Inc. EBA Class I 1984-07-31
K842392 DELTON * OPAQUE LIGHT CURING PIT Johnson & Johnson Professionals, Inc. EBC Class II 1984-07-26
K833270 ASTRON 77 INJECTION DENTURE RESIN Astron Dental Corp. EBI Class II 1984-07-19
K842006 CITOJECT CARTRIDGE SYRINGE Miles Laboratories, Inc. EJI Class II 1984-07-16
K841910 KERR SEALAPEX ROOT CANAL SEALER Sybron Corp. EJK Class II 1984-07-13
K841491 CONVENTIONAL PLASTIC DENTAL TRAYS Buffalo Dental Mfg. Co., Inc. EHY Class I 1984-07-13
K841826 NATURA-DENT VACUUM-FIRED PORCELAIN TEETH Parexel Intl. Corp. ELL Class II 1984-07-12
K842087 BISFIL-I LIGHT CURABLE POSTERIOR COMPO Bisco, Inc. EBF Class II 1984-07-12
K842078 JOHNSON & JOHNSON FLAVORED ETCHING GEL Johnson & Johnson Professionals, Inc. KLE Class II 1984-07-12
K842026 H-TYPE BRIDGE REMOVER Higa Manufacturing , Ltd. EIS Class I 1984-07-11
K841327 DENTAL COTTON ROLLS Intl. Verbandstoff-Fabrik Schaffhau EFN Class I 1984-07-03
K841077 ARK TONGUE CLEANER Arkay Co. LCN Class I 1984-07-02
K841675 FLOSS N' GLOSS/SAFETY FLOSS MED DEVICE Leonard Lorch JES Class I 1984-06-27
K841323 FUZZY TRAY Buffalo Dental Mfg. Co., Inc. EHY Class I 1984-06-27
K841638 ALINE ORTHODONTIC ARCHWIRE A Company, Inc. DZC Class I 1984-06-27
K841290 STELDENT - DENTAL ALLOY Eriez EJH Class II 1984-06-27
K840726 RESTODENT DENTIN BONDING AGENT Lee Pharmaceuticals KLE Class II 1984-06-27
K841490 POLYSULFIDE CUSTOM TRAY MATERIAL Buffalo Dental Mfg. Co., Inc. ELW Class II 1984-06-27
K841550 SCOTCHBOND LIGHT CURED DENTAL ADHES 3M Company EBF Class II 1984-06-22
K841551 OSSEOINTEGRATED FIXTURES-TISSUE INTEGR Bofors Nobelpharma, Inc. DZE Class II 1984-06-22
K841801 DENTURE CLEANSER Miracle Clean, Inc. EFT Class I 1984-06-22
K840955 CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD Synthes (Usa) JEY Class II 1984-06-19
K841011 ELEVATOR - VARIOUS Premier Dental Products Co. EMS Class I 1984-06-15
K841269 C-19 Pentron Corp. EBF Class II 1984-05-22
K841457 NUMBER 21 R/R SYSTEM Pentron Corp. KLE Class II 1984-05-22
K841458 NUMBER 20 R/L SYSTEM Pentron Corp. KLE Class II 1984-05-22
K841667 WUNDERFIL Harry J. Bosworth Co. EBF Class II 1984-05-22
K841268 C-17 Pentron Corp. EBF Class II 1984-05-22
K840407 KERR RESIN BONDED BRIDGE CEMENT Sybron Corp. EMA Class II 1984-05-21
K841518 JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II) Johnson & Johnson Professionals, Inc. EBF Class II 1984-05-21
K841195 GLAS IONOMER CEMENT Shofu Dental Corp. EMA Class II 1984-05-14
K841196 HY-BOND ZINC OXIDE EUGENOL TEMP. Shofu Dental Corp. EMA Class II 1984-05-11
K840751 OPAQUE COATING & SURFACE STAIN Dentsply Intl. EBD Class II 1984-05-11
K833310 FOGCUTTER DENTAL MOUTH MIRROR Hti, Inc. EAX Class I 1984-05-07
K840561 RX ELAN Jeneric Ind. EJS Class II 1984-05-01
K840563 RX C & B 20 Jeneric Ind. EJS Class II 1984-05-01
K840244 BIOCERAM ZEST PLANT Zest Anchors, Inc. DZE Class II 1984-05-01
K840405 BOSWORTH DENT-ALL Harry J. Bosworth Co. EBI Class II 1984-05-01
K840600 MAGNE-DENT Magne-Dent EGG Class I 1984-04-30
K841267 C-18 Pentron Corp. EBF Class II 1984-04-30
K840690 DENTAL HANDPIECE Pen-Med Technology, Inc. EFB Class I 1984-04-25
K840873 CRYSTAR PORCELAIN MARGIN POWDER/LIQUID Shofu Dental Corp. EIH Class II 1984-04-25
K841199 FIBERGLASS MOUTH MIRRORS Henry Schein, Inc. EAX Class I 1984-04-25
K840254 DIAMOND LUSTRE Jelrus Technical Products Corp. EJR Class I 1984-04-25
K833797 LIGHT CURED RESIN BONDED CERAMIC 3M Company EBF Class II 1984-04-25
K840721 PERIO PIK Teledyne, Inc. EFS Class I 1984-04-25
K840720 FIBER HEMOFILTERS FH55-FH77 & 88 Gambro, Inc. KOJ Class II 1984-04-24
K840548 RESIL Parker Laboratories, Inc. EBI Class II 1984-04-17
K840176 ESTIC MICROFILL Kulzer, Inc. EBF Class II 1984-04-13
K840562 REX V Jeneric Ind. EJH Class II 1984-04-13
K840750 HYDROXYLAPATITE COATED ENDOSSEOUS DENT Calcitek, Inc. DZE Class II 1984-04-13
K840984 INTERDENTAL WEDGES Healthco, Inc. DZN Class I 1984-04-13
K840727 PENTRA-FIL II Pentron Corp. EBF Class II 1984-04-13
K834446 ALEXOTEK LINGUAL TUBES Alexotek Co. DZD Class I 1984-04-05
K840093 DENTAL FLOSSING INSTRUMENT Leverette Corp. JES Class I 1984-04-05
K840260 PERIOGRAF DURAPATITE 40-60 MESH Sterling Drug, Inc. LYC Class II 1984-04-05
K840237 MAX-I-PROBE PERIODONTAL ENDODONTIC PROB Smith & Nephew, Mpl Division EIC Class I 1984-04-05
K840312 CAT. 8 DENTAL DEVICES Imm Enterprises , Ltd. EMG Class I 1984-04-05
K840805 ORAL SAFE Great Lakes Orthodontics, Ltd. JER Class I 1984-03-30
K840084 COLTENE BRILLIANT LUX Bauer, Cheng & Associates, Inc. EBF Class II 1984-03-30
K840642 THERMOCRAFT PORCELAIN American Thermocraft Corp. ELL Class II 1984-03-30
K840014 CHEMODENT CERAMIC METAL Chemodent Metal Co. EJS Class II 1984-03-30
K833304 HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST Smith & Nephew, Mpl Division DZM Class I 1984-03-30
K834545 POCKETIP 4414 Vipont Laboratories, Inc. EFS Class I 1984-03-30
K833725 PRE-LOADED C-R TUBES FOR SYRINGE Centrix, Inc. EBF Class II 1984-03-30
K841111 REMBRANDT SHADE MODIFICATION KIT Den-Mat Corp. EBF Class II 1984-03-30
K840297 COLTENE ORALLOY MAGICAPS Coltene, Inc. EJJ Class II 1984-03-16
K840275 CEHPALOMETRIC HEAD POSITIONER Gary E. Hall, Dds EAH Class I 1984-03-16
K832674 SATELEC PROPHY UNIT PU 2000S Spelna, Inc. ELC Class II 1984-03-16
K840141 DENTAL ULTRASONIC SCALER/ENDOSONIC CooperVision, Inc. ELC Class II 1984-03-16
K834283 DENTSPLY G-106 CAVITRON ULTRASONIC Coopercare, Inc. ELC Class II 1984-03-16
K832664 SATELEC SUPRASSON PIEZOMATIC P2 Spelna, Inc. ELC Class II 1984-03-16
K840085 COLTENE BRILLIANT Bauer, Cheng & Associates, Inc. EBF Class II 1984-03-16
K834497 SHOFU PORCELAIN STAIN Shofu Dental Corp. EIH Class II 1984-03-06
K834364 CRYSTALLINE BONE SCREW ENDO-OSSEOUS C.B.S. Biotechnics, Inc. DZE Class II 1984-03-06
K834190 JAKOBI SURG. INSTRUMENTS #8 15 Imm Enterprises , Ltd. EMH Class I 1984-03-06
K834361 JSB JET SYRINGE C.B.S. Biotechnics, Inc. EGM Class II 1984-03-05
K833838 SILVERAK Anil S. Gautam LCN Class I 1984-03-02
K832919 OPTI-BEAM IV Dentsply Intl. EAZ Class I 1984-03-02
K834392 LABIAL CUSPID TUBE Alexotek Co. DZD Class I 1984-02-28
K834409 DENTURE BASE RESIN Dentsply Intl. EBI Class II 1984-02-27
K833640 HYDROXYLINE George Taub Products & Fusion Co., Inc. EJK Class II 1984-02-27
K834363 ENDIX RADICULAR BIOCERAMIC PIN C.B.S. Biotechnics, Inc. ELS Class II 1984-02-27
K834560 VITEX P.D.A Jeneric Ind. EJH Class II 1984-02-27
K833056 UNIVERSAL LINE-A-PLATE Laurentian Laboratories EBO Class II 1984-02-27
K834366 SURGICAL INSTRUMENTS & ACCESSORIES C.B.S. Biotechnics, Inc. EMH Class I 1984-02-27
K833057 UNIVERSAL FIX-A-PLATE Laurentian Laboratories EBO Class II 1984-02-27
K834055 VANADIUM EXCAVATORS SIZES 0-6 Henry Schein, Inc. EKC Class I 1984-02-21

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