Atlas FDA

DZP

21 FDA 510(k) clearances · Product code

56 daysmedian time to decision
151 days90th percentile
21clearances measured

FDA profile

Official device name
Instrument, Diamond, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4535
Medical specialty
Dental
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
BLUWHITE DIAMOND DENTAL BURS MODIFIED (K120037)Beavers Dental, Div. Sybron Canada, Ltd.2012-04-20
SOPHOS DENTAL DIAMOND (K943841)Sophos Technologic1994-09-16
DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS (K940908)Dunhall Pharmaceuticals, Inc.1994-08-29
DENTAL DRILL (K934981)Eare Consulting Service1994-02-03
DENTAL DIAMOND DRILLS (K923757)Alpha Industrializacao DE Metais Ltda.1993-03-16
MANI DIA-BURS (K913651)The Lahr Consulting Group, Inc.1992-01-14
DENDIA WERK BURS AND CUTTING DISCS (K901967)Micro-Aire Surgical Instruments, Inc.1990-07-13
F.G. LASER (DENTAL BUR) (K901262)Diamond Rotary and Carbide Intl.1990-07-09
FG DIAMOND BURRS (K900089)Kab Gloves Unltd.1990-04-03
3D DENTAL DIAMOND ROTARY INSTRUMENTS (K893844)Lustgarten Multi-Tech International, Inc.1989-08-11
NOVA DIAMOND (K885233)Microcopy, Div. Neo-Flo, Inc.1989-02-13
BEAVERS' DENTAL DIAMOND INSTRUMENTS (K880179)Beavers Dental, Div. Sybron Canada, Ltd.1988-03-09
DENTAL DIAMOND BURS (K871639)E&D Dental Manufacturing Co.1987-05-18
HYBRID POINTS (K854347)Shofu Dental Corp.1985-12-27
SUMMA DISK (K833038)Shofu Dental Corp.1983-10-04
GINGI CURETTAGE DIAMOND POINTS (K832856)Shofu Dental Corp.1983-10-04
TPE DIAMOND POINTS (K832855)Shofu Dental Corp.1983-09-29
MEISINGER DIAMOND DENTAL BURS (K802984)Swiss American Metal Craft Corp.1980-12-30
JOTA DIAMOND DENTAL BURS (K802987)Swiss American Metal Craft Corp.1980-12-30
DIAMOND STONES (K780864)Venture Technology, Inc.1978-06-14
DIAMOND STONES (K760987)Adp Intl., Inc.1976-11-15

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Every clearance here is in the API, with alerts when new ones post.