510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K851073Substantially Equivalent

Cuprident

Bio Systems, Inc., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851073 is the FDA 510(k) clearance record for CUPRIDENT, a class I device, cleared for Bio Systems, Inc. on under FDA product code EJR (Agent, Polishing, Abrasive, Oral Cavity). FDA records list 2 510(k) clearances for Bio Systems, Inc., from to . As of , FDA records show no recalls naming K851073.

Clearance record

Decision date
Received
(135 days to decision)
Product code
EJR Agent, Polishing, Abrasive, Oral Cavity
Regulation
21 CFR 872.6030
Device class
Class I
Review panel
Dental
Applicant
Bio Systems, Inc. 3567 Blue Rock Rd., Cincinnati OH
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