Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

EGD — Predicate Candidate Screening

25 FDA 510(k) clearances under this product code; the 50 most recent screened below.

61 daysmedian FDA review time

187 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K020009	BRACE EZE	Udent, Inc.	2002-02-11	40
K945535	GLENROE ORTHO-SIL	Glenroe Technologies	1995-01-27	74
K924024	ORTHO WAX	Heraeus Kulzer, Inc.	1992-11-17	98
K923586	BURNOUT MATERIAL	Dentsply Intl.	1992-09-29	71
K914892	SALIVA-STIM	Orion Diagnostica, Inc.	1992-09-02	307
K922380	BITE RIM WAX	Dentsply Intl.	1992-06-16	27
K914513	PALAVIT G	Heraeus Kulzer, Inc.	1992-03-19	162
K910676	INTRAORAL DENTAL WAX	Pemaco, Inc.	1991-08-21	187
K904928	PALAVIT GLC	Kulzer, Inc.	1991-06-06	218
K895562	PEMACO 2000 INTRAORAL DENTAL WAX	Pemaco, Inc.	1989-11-06	61
K895561	PEMACO 3000 INTRAORAL DENTAL WAX	Pemaco, Inc.	1989-11-06	61
K895563	PEMACO BITE WAX SHEETS	Pemaco, Inc.	1989-11-06	61
K895566	PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT	Pemaco, Inc.	1989-11-06	61
K895564	PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD	Pemaco, Inc.	1989-11-06	61
K895565	PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD	Pemaco, Inc.	1989-10-24	48
K880607	UTILITY WAX STRIPS, SPEARMINT	Columbus Dental Mfg. Co.	1988-03-31	48
K880606	UTILITY WAX STRIPS, CINNAMON	Columbus Dental Mfg. Co.	1988-03-24	41
K863758	ORTHO-BITE WAX WAFER	Columbus Dental Mfg. Co.	1986-10-07	12
K854529	INLAY WAX REGULAR	The Hygenic Corp.	1986-03-10	117
K854527	STICKY WAX	The Hygenic Corp.	1986-03-04	111
K854530	PREMIUM FLEXI-TOUGH	The Hygenic Corp.	1986-03-04	111
K850915	WAX BITE IMPRESSION WAFER	Toothprints, Inc.	1985-04-16	42
K812804	MODERN MATERIALS' INLAY CSTG. WAXES,A-C	Modern Materials	1982-01-26	112
K812805	STEELE'S ECON. PINK BASEPL. WAXES, I-III	Modern Materials	1982-01-12	98
K801911	HOWMEDICA BITE BLOCK	Howmedica Corp.	1980-08-27	16

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda