510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912997Substantially Equivalent

Miniflex and Personal Unit

Dabi-Atlante America Corp., Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912997 is the FDA 510(k) clearance record for MINIFLEX AND PERSONAL UNIT, a class I device, cleared for Dabi-Atlante America Corp. on under FDA product code EAZ (Light, Operating, Dental). FDA records list 4 510(k) clearances for Dabi-Atlante America Corp., from to . As of , FDA records show no recalls naming K912997.

Clearance record

Decision date
Received
(114 days to decision)
Product code
EAZ Light, Operating, Dental
Regulation
21 CFR 872.4630
Device class
Class I
Review panel
Dental
Applicant
Dabi-Atlante America Corp. 5453 W. Waters Ave. Suite 200, Tampa FL
510(k) summary
Statement
Third party review
No

Clearances, product code EAZ

Trailing 12 months

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

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