510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K771908Substantially Equivalent

ISO-Shield Saliva Absorbers

3M Company, White City OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771908 is the FDA 510(k) clearance record for ISO-SHIELD SALIVA ABSORBERS, a class I device, cleared for 3M Company on under FDA product code KHR (Absorber, Saliva, Paper). FDA records list 54 510(k) clearances for 3M Company, from to . As of , FDA records show no recalls naming K771908.

Clearance record

Decision date
Received
(27 days to decision)
Product code
KHR Absorber, Saliva, Paper
Regulation
21 CFR 872.6050
Device class
Class I
Review panel
Dental
Applicant
3M Company 8124 Pacific Ave., White City OR
Third party review
No

Clearances, product code KHR

Trailing 12 months

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

FDA records show no clearances under product code KHR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KHR, 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