510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163171Substantially Equivalent

CeraClean

Bisco Inc, Schaumburg IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163171 is the FDA 510(k) clearance record for CeraClean, a class II device, cleared for Bisco, Inc. on under FDA product code PME (External Cleaning Solution). FDA's definition for product code PME reads: "For use on dental restorations, external to the mouth, prior to insertion into the mouth". FDA records list 57 510(k) clearances for Bisco, Inc., from to . As of , FDA records show no recalls naming K163171.

Clearance record

Decision date
Received
(151 days to decision)
Product code
PME External Cleaning Solution
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Bisco, Inc. 1100 W. Irving Park Rd., Schaumburg IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PME

Trailing 12 months

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

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