Atlas FDA

EKN

7 FDA 510(k) clearances · Product code

22 daysmedian time to decision
162 days90th percentile
7clearances measured

FDA profile

Official device name
Point, Paper, Endodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.3830
Medical specialty
Dental
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RecordFirmDate
ABSORBENT ENDODONTIC POINT (K843017)United Dental Mfg., Inc.1985-01-09
ENDODONTIC PAPERPOINTS (K821625)Roeko1982-06-14
ENDODONTIC PAPER POINTS (K812886)United Dental Mfg., Inc.1981-11-16
PREMIER ABSORBENT POINTS (K800827)Premier Dental Products Co.1980-04-29
R&R ABSORBENT POINTS (K781605)Ransom and Randolph1978-10-10
ABSORBENT POINTS (K761203)Johnson & Johnson Professionals, Inc.1976-12-13
ENDODONTIC INSTRUMENTS (K760983)Adp Intl., Inc.1976-11-15

Track EKN automatically

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