Atlas FDA

EGD

25 FDA 510(k) clearances · Product code

61 daysmedian time to decision
187 days90th percentile
25clearances measured

FDA profile

Official device name
Wax, Dental, Intraoral
Device class
Class I (low risk)
Regulation
21 CFR 872.6890
Medical specialty
Dental
Flags
GMP exempt
Adverse events (MAUDE)
2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BRACE EZE (K020009)Udent, Inc.2002-02-11
GLENROE ORTHO-SIL (K945535)Glenroe Technologies1995-01-27
ORTHO WAX (K924024)Heraeus Kulzer, Inc.1992-11-17
BURNOUT MATERIAL (K923586)Dentsply Intl.1992-09-29
SALIVA-STIM (K914892)Orion Diagnostica, Inc.1992-09-02
BITE RIM WAX (K922380)Dentsply Intl.1992-06-16
PALAVIT G (K914513)Heraeus Kulzer, Inc.1992-03-19
INTRAORAL DENTAL WAX (K910676)Pemaco, Inc.1991-08-21
PALAVIT GLC (K904928)Kulzer, Inc.1991-06-06
PEMACO 2000 INTRAORAL DENTAL WAX (K895562)Pemaco, Inc.1989-11-06
PEMACO 3000 INTRAORAL DENTAL WAX (K895561)Pemaco, Inc.1989-11-06
PEMACO BITE WAX SHEETS (K895563)Pemaco, Inc.1989-11-06
PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT (K895566)Pemaco, Inc.1989-11-06
PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD (K895564)Pemaco, Inc.1989-11-06
PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD (K895565)Pemaco, Inc.1989-10-24
UTILITY WAX STRIPS, SPEARMINT (K880607)Columbus Dental Mfg. Co.1988-03-31
UTILITY WAX STRIPS, CINNAMON (K880606)Columbus Dental Mfg. Co.1988-03-24
ORTHO-BITE WAX WAFER (K863758)Columbus Dental Mfg. Co.1986-10-07
INLAY WAX REGULAR (K854529)The Hygenic Corp.1986-03-10
STICKY WAX (K854527)The Hygenic Corp.1986-03-04
PREMIUM FLEXI-TOUGH (K854530)The Hygenic Corp.1986-03-04
WAX BITE IMPRESSION WAFER (K850915)Toothprints, Inc.1985-04-16
MODERN MATERIALS' INLAY CSTG. WAXES,A-C (K812804)Modern Materials1982-01-26
STEELE'S ECON. PINK BASEPL. WAXES, I-III (K812805)Modern Materials1982-01-12
HOWMEDICA BITE BLOCK (K801911)Howmedica Corp.1980-08-27

Track EGD automatically

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