510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861338Substantially Equivalent

Dental Cotton Rolls, Sterile and Non-Sterile

Intl. Verbandstoff-Fabrik Schaffhau, Switzlerland, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861338 is the FDA 510(k) clearance record for DENTAL COTTON ROLLS, STERILE AND NON-STERILE, a class I device, cleared for Intl. Verbandstoff-Fabrik Schaffhau on under FDA product code EFN (Cotton, Roll). FDA records list 2 510(k) clearances for Intl. Verbandstoff-Fabrik Schaffhau, from to . As of , FDA records show no recalls naming K861338.

Clearance record

Decision date
Received
(121 days to decision)
Product code
EFN Cotton, Roll
Regulation
21 CFR 872.6050
Device class
Class I
Review panel
Dental
Applicant
Intl. Verbandstoff-Fabrik Schaffhau Ch-8212 Neuhausen Am Rheinfall, Switzlerland, CH
Third party review
No

Clearances, product code EFN

Trailing 12 months

FDA records hold no clearances under product code EFN in the trailing twelve months.

FDA records show no clearances under product code EFN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EFN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260