Atlas FDA

DZC

30 FDA 510(k) clearances · Product code

126 daysmedian time to decision
188 days90th percentile
30clearances measured

FDA profile

Official device name
Wire, Orthodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.5410
Medical specialty
Dental
Adverse events (MAUDE)
2004: 3 · 2005: 30 · 2006: 37 · 2007: 33 · 2008: 143 · 2009: 34
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
HYPERELASTIC WIRE (K112640)Ormco Corp.2011-11-16
HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT (K943334)Jay H. Geller1994-10-05
NITINOL, NITI (K935638)Highland Metals1994-05-18
DENTAURUM STEEL LIGATURE WIRES (K935140)Dentauraum, Inc.1994-02-04
DENTAURUM WIRES (K935142)Dentauraum, Inc.1994-01-31
FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE (K934265)Flexmedics1994-01-21
NITI COIL SPRINGS (K933374)Highland Metals1993-11-19
STAINLESS STEEL ARCHES REPACKER RELABETER (K933377)Highland Metals1993-11-16
REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER (K933378)Highland Metals1993-11-12
REVERSE SURVE NITI ARCH WIRE (K933380)Highland Metals1993-11-12
STAINLESS STEEL ARCHES (K933379)Highland Metals1993-11-12
NITI ARCH WIRE ON A SPOOL (K933376)Highland Metals1993-11-12
COATED ORTHODONTIC DEVICES (K931631)Wonder Wire1993-07-28
TITAN SEPARATING SPRING (K930202)Ortho Spectrum, Inc.1993-05-27
ORTHODONTIC ARCH WIRE (K924805)Ultimate Wireforms, Inc.1993-03-31
DIMPLED MULTI MODULUS ARCH WIRE (K923837)Ultimate Wireforms, Inc.1993-03-31
.016' X .016 NICKEL TITANIUM UPRIGHTING SPRING (K923836)Ultimate Wireforms, Inc.1992-12-23
THE ULTIMATE RCS ARCH WIRE (K923838)Ultimate Wireforms, Inc.1992-12-04
BIOFORCE WIRE (K920905)Gac Intl., Inc.1992-11-04
NITINOL GENTLE TOUCH COIL SPRING (K923839)Ultimate Wireforms, Inc.1992-10-15
GAC THUMB-SUCKING CONTROL APPLIANCE (K920850)Gac Intl., Inc.1992-08-24
FLEXMEDICS NITINOL ARCH WIRE (K863742)Flexmedics1986-11-24
INTERPORE 200 POROUS HYDROXYAPATITE (K852975)Inrterpore Intl.1985-10-31
A COMPANY BRASS SEPARATING RINGS (K851878)A Company, Inc.1985-06-05
SENTINOL -ORTHODONTIC ARCH WIRE (K851055)Gac Intl., Inc.1985-05-09
FILAFEX TM, ESTHETIC ORTHODONTIC WIRE (K843171)Berkley and Co.1984-12-03
ORTHODONTIC WIRE (K843722)Arthur L. Wool1984-11-09
ALINE ORTHODONTIC ARCHWIRE (K841638)A Company, Inc.1984-06-27
FILAFEX ESTHETIC ORTHODINIC WIRE (K833788)Berkley and Co.1984-01-24
PAC-AID (K812454)Albert J. Anthony, Dmd1981-09-23

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