510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915207Substantially Equivalent

Disposable Radiolucent Rubber Dam Clamp

Bay Technical Products, Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915207 is the FDA 510(k) clearance record for DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP, a class I device, cleared for Bay Technical Products, Inc. on under FDA product code EEF (Clamp, Rubber Dam). FDA records list one 510(k) clearance for Bay Technical Products, Inc. As of , FDA records show no recalls naming K915207.

Clearance record

Decision date
Received
(88 days to decision)
Product code
EEF Clamp, Rubber Dam
Regulation
21 CFR 872.6300
Device class
Class I
Review panel
Dental
Applicant
Bay Technical Products, Inc. 1895 Mowry Ave., Suite 110, Fremont CA
510(k) summary
Statement
Third party review
No

Clearances, product code EEF

Trailing 12 months

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

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