Atlas FDA

ECI

25 FDA 510(k) clearances · Product code

108 daysmedian time to decision
312 days90th percentile
25clearances measured

FDA profile

Official device name
Band, Elastic, Orthodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.5410
Medical specialty
Dental
Adverse events (MAUDE)
1994: 1 · 1996: 1 · 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
POWER COINS GLOW IN THE DARK LIGATURES (K980864)Ortho Kinetics Corp.1998-04-20
GLENROE CHAIN (K980053)Glenroe Technologies1998-02-24
GLENROE GLOW IN DARK ELASTOMERIC LIGATURES (K973495)Glenroe1997-12-01
ORTHODONTIC ELASTOMERIC LAGATURE MODULE (K943419)Jon-Ko Products, Inc.1995-05-24
ORTHODONTIC ELASTOMERIC CHAIN (K943420)Jon-Ko Products, Inc.1995-05-23
ORTHODONTIC ELASTOMERIC SEPARATOR MODULE (K943418)Jon-Ko Products, Inc.1995-05-23
ORTHODONTIC ELASTOMERIC TUBE/THREAD (K943417)Jon-Ko Products, Inc.1995-05-23
ALASTIK (K940165)Unitek Corp.1994-03-07
PRO'S NEO-LASTICS (K932298)Professional Positioners, Inc.1994-02-14
DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS (K935144)Dentauraum, Inc.1994-02-04
ORTHODONTIC ELASTOMER (K932319)Gac Intl., Inc.1993-09-20
GLENROE CHAIN (K931462)Glenroe Technologies, Inc.1993-07-22
ALASTIK NS (K923999)Unitek Corp.1993-06-24
SINGLES (K930453)Nexadental1993-05-27
TUFF TIES (K924140)Glenroe Technologies1993-04-27
GLENROE ORTHO SEPS (K924139)Glenroe Technologies1993-04-08
UNI-STICK PLASTIC LIGATURE, MODIFIED (K926578)American Orthodontics1993-03-31
RUBBER BAND, STERILE (K882695)Bioseal1988-10-13
A-COMPANY SEPARATING ELASTICS (K852598)A Company, Inc.1985-07-31
A-COMPANY ELASTIC LIGATURE RINGS (K852596)A Company, Inc.1985-07-31
A-COMPANY ELASTOMERIC TUBING (K852599)A Company, Inc.1985-07-31
A-COMPANY ELASTIC ROTATION WEDGES (K852597)A Company, Inc.1985-07-31
A-COMPANY ELASTOMERIC CHAIN DISPENSER (K852600)A Company, Inc.1985-07-31
ORTHODONTIC ELASTICS (K810010)Orec Corp.1981-01-28
HYGIENIC ANCHORINGS (K780804)Hygienic Dental Mfg., Co., The1978-06-14

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