Atlas FDA

EFN

14 FDA 510(k) clearances · Product code

32 daysmedian time to decision
143 days90th percentile
14clearances measured

FDA profile

Official device name
Cotton, Roll
Device class
Class I (low risk)
Regulation
21 CFR 872.6050
Medical specialty
Dental
Flags
GMP exempt
Adverse events (MAUDE)
2000: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
STRUNG DENTAL ROLLS (K872810)American Silk Sutures, Inc.1987-12-04
MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER (K871464)Medgroup Enterprises, Inc.1987-04-30
COTTON ROLLS, NON-STERILE (K863764)The Medical Group, Inc.1986-10-27
DENTAL COTTON ROLLS, STERILE AND NON-STERILE (K861338)Intl. Verbandstoff-Fabrik Schaffhau1986-08-06
COTTON FILLED GAUZE SPONGES 2 X 2 (K861727)Cross Country Paper Products Corp.1986-07-10
TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- (K843539)Molnlycke A/S Hospital Products1985-05-23
DENTAL COTTON ROLLS (K841327)Intl. Verbandstoff-Fabrik Schaffhau1984-07-03
SCHEIN COTTON ROLLS, NON-STERILE (K834056)Henry Schein, Inc.1984-02-03
STERILE COTTON ROLLS #3, 1 1/2 (K830175)Veratex Corp.1983-02-18
STERILE DENTAL ROLL (K812709)Medspec Corp.1981-10-23
HOYT COTTON ROLLS (K810830)Hoyt Laboratories1981-04-14
COTTON ROLLS (K802429)Worldwide Surgical Gauze1980-10-23
COTTON ROLL COMPRESSION CAPS (K792391)Parker Laboratories, Inc.1979-12-06
DISP. ABSORBENT COMPRESSED FIBRE WAFER (K770063)Lorvic Corp.1977-01-14

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