510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K132245Substantially Equivalent

Ajax Dental Unit

Pro Dental Services, LLC, Herndon VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132245 is the FDA 510(k) clearance record for AJAX DENTAL UNIT, a class I device, cleared for Pro Dental Services, LLC on under FDA product code EIA (Unit, Operative Dental). FDA records list one 510(k) clearance for Pro Dental Services, LLC. As of , FDA records show no recalls naming K132245.

Clearance record

Decision date
Received
(414 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Pro Dental Services, LLC 1121 Player Way, Herndon VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EIA

Trailing 12 months
2 clearances under product code EIA in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EIA, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260