510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K051664Substantially Equivalent

Scan300fp / Retropan (Vdc)

Oy Ajat, Ltd., Ormond Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K051664 is the FDA 510(k) clearance record for SCAN300FP / RETROPAN (VDC), a class II device, cleared for Oy Ajat, Ltd. on under FDA product code MUH (System, X-Ray, Extraoral Source, Digital). FDA records list one 510(k) clearance for Oy Ajat, Ltd. As of , FDA records show no recalls naming K051664.

Clearance record

Decision date
Received
(28 days to decision)
Product code
MUH System, X-Ray, Extraoral Source, Digital
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Oy Ajat, Ltd. 110 E. Granada Blvd., Suite 207, Ormond Beach FL
510(k) summary
Statement
Third party review
No

Clearances, product code MUH

Trailing 12 months
3 clearances under product code MUH 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 MUH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260