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
K102053Substantially Equivalent

Butler Calci-Flor Prophylaxis Paste

Sunstar Americas, Inc., Lake Bluff IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102053 is the FDA 510(k) clearance record for BUTLER CALCI-FLOR PROPHYLAXIS PASTE, a class I device, cleared for Sunstar Americas, Inc. on under FDA product code EJR (Agent, Polishing, Abrasive, Oral Cavity). FDA records list 3 510(k) clearances for Sunstar Americas, Inc., from to . As of , FDA records show no recalls naming K102053.

Clearance record

Decision date
Received
(196 days to decision)
Product code
EJR Agent, Polishing, Abrasive, Oral Cavity
Regulation
21 CFR 872.6030
Device class
Class I
Review panel
Dental
Applicant
Sunstar Americas, Inc. 10 E. Scanton Ave., Suite 201, Lake Bluff IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EJR

Trailing 12 months

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

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