510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K851045Substantially Equivalent

Dent-Dr. Vacu-Frame

Dent-Dr., Grand Rapids MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851045 is the FDA 510(k) clearance record for DENT-DR. VACU-FRAME, a class I device, cleared for Dent-Dr. on under FDA product code EIE (Dam, Rubber). FDA records list one 510(k) clearance for Dent-Dr. As of , FDA records show no recalls naming K851045.

Clearance record

Decision date
Received
(39 days to decision)
Product code
EIE Dam, Rubber
Regulation
21 CFR 872.6300
Device class
Class I
Review panel
Dental
Applicant
Dent-Dr. 2415 Pebble Brook SE, Grand Rapids MI
Third party review
No

Clearances, product code EIE

Trailing 12 months

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

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