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

ECI — Predicate Candidate Screening

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

108 daysmedian FDA review time

312 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K980864	POWER COINS GLOW IN THE DARK LIGATURES	Ortho Kinetics Corp.	1998-04-20	46
K980053	GLENROE CHAIN	Glenroe Technologies	1998-02-24	49
K973495	GLENROE GLOW IN DARK ELASTOMERIC LIGATURES	Glenroe	1997-12-01	76
K943419	ORTHODONTIC ELASTOMERIC LAGATURE MODULE	Jon-Ko Products, Inc.	1995-05-24	313
K943420	ORTHODONTIC ELASTOMERIC CHAIN	Jon-Ko Products, Inc.	1995-05-23	312
K943418	ORTHODONTIC ELASTOMERIC SEPARATOR MODULE	Jon-Ko Products, Inc.	1995-05-23	312
K943417	ORTHODONTIC ELASTOMERIC TUBE/THREAD	Jon-Ko Products, Inc.	1995-05-23	312
K940165	ALASTIK	Unitek Corp.	1994-03-07	60
K932298	PRO'S NEO-LASTICS	Professional Positioners, Inc.	1994-02-14	279
K935144	DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTIC	Dentauraum, Inc.	1994-02-04	99
K932319	ORTHODONTIC ELASTOMER	Gac Intl., Inc.	1993-09-20	132
K931462	GLENROE CHAIN	Glenroe Technologies, Inc.	1993-07-22	120
K923999	ALASTIK NS	Unitek Corp.	1993-06-24	318
K930453	SINGLES	Nexadental	1993-05-27	120
K924140	TUFF TIES	Glenroe Technologies	1993-04-27	252
K924139	GLENROE ORTHO SEPS	Glenroe Technologies	1993-04-08	233
K926578	UNI-STICK PLASTIC LIGATURE, MODIFIED	American Orthodontics	1993-03-31	191
K882695	RUBBER BAND, STERILE	Bioseal	1988-10-13	108
K852598	A-COMPANY SEPARATING ELASTICS	A Company, Inc.	1985-07-31	42
K852596	A-COMPANY ELASTIC LIGATURE RINGS	A Company, Inc.	1985-07-31	42
K852599	A-COMPANY ELASTOMERIC TUBING	A Company, Inc.	1985-07-31	42
K852597	A-COMPANY ELASTIC ROTATION WEDGES	A Company, Inc.	1985-07-31	42
K852600	A-COMPANY ELASTOMERIC CHAIN DISPENSER	A Company, Inc.	1985-07-31	42
K810010	ORTHODONTIC ELASTICS	Orec Corp.	1981-01-28	23
K780804	HYGIENIC ANCHORINGS	Hygienic Dental Mfg., Co., The	1978-06-14	34

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