510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790325Substantially Equivalent

Reprodent

Premier Dental Products Co, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790325 is the FDA 510(k) clearance record for REPRODENT, a class II device, cleared for Premier Dental Products Co. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 44 510(k) clearances for Premier Dental Products Co., from to . As of , FDA records show no recalls naming K790325.

Clearance record

Decision date
Received
(15 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Premier Dental Products Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code EBI

Trailing 12 months
10 clearances under product code EBI in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
November 20253
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260