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FDA Product Code

FDA Product Code KLE — Clearance Directory

Device Class
Class II
Assigned Panel
Dental
21 CFR Citation
872.3200

510(k) Clearances — 420 records · page 5 of 5

K-Number Device Name Applicant Decision Date Clearance Type Summary
K830387 MICRODAPT DENTAL RESTORATIVE BONDING Johnson & Johnson Professionals, Inc. 1983-03-17 Traditional PDF ↗
K822451 AURAFILL* DENTAL RESTORATIVE BONDING AG. Johnson & Johnson Professionals, Inc. 1982-09-07 Traditional PDF ↗
K813180 SCOTCHBOND DENTAL ADHESIVE 3M Company 1982-01-12 Traditional PDF ↗
K812116 PERMAGUM Espe-Premier Sales Co. 1981-08-31 Traditional PDF ↗
K812117 PERMAGUM ADHESIVE Espe-Premier Sales Co. 1981-08-31 Traditional PDF ↗
K810407 HYDROXYLATE ENAMEL BOND SYSTEM Wallace A. Erickson & Co. 1981-03-17 Traditional PDF ↗
K810265 VISIO-BAND Espe-Premier Sales Co. 1981-02-23 Traditional PDF ↗
K802681 HELIOBOND Vivadent (Usa), Inc. 1980-11-24 Traditional PDF ↗
K802333 INSTANT BRIDGE Scientific Pharmaceuticals, Inc. 1980-11-12 Traditional PDF ↗
K801216 DEN-MAT DENTIN BONDING AGENT Den-Mat Corp. 1980-05-28 Traditional PDF ↗
K801093 PRISMA-BOND Dentsply Intl. 1980-05-20 Traditional PDF ↗
K800389 ANTERIOR & POST. RESTORATIVE PASTE SYS. American Dental Research 1980-04-10 Traditional PDF ↗
K800390 ANT. & POST. RESTORATIVE POWDER LIQ. American Dental Research 1980-04-10 Traditional PDF ↗
K790833 VISIO-BOND Espe GmbH (Us) 1979-04-30 Traditional PDF ↗
K782080 VENEER SYSTEM, MOSTIQUE LAMINATE Caulk Co., Div. Dentsply 1979-01-26 Traditional PDF ↗
K771328 UVIOBOND Espe GmbH (Us) 1977-08-03 Traditional PDF ↗
K771325 NIMETIC ETCHING GEL Espe GmbH (Us) 1977-08-02 Traditional PDF ↗
K771326 NIMETIC BONDING MATERIAL Espe GmbH (Us) 1977-08-02 Traditional PDF ↗
K760400 BONDING AGENT, VYTOL L.D. Caulk Co. 1976-08-23 Traditional PDF ↗
K760324 BONDING AGENT, PRESTIGE Lee Pharmaceuticals 1976-08-03 Traditional PDF ↗

Product code KLE · Class II · Dental. Data: openFDA.