510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K111249Substantially Equivalent

Orthoslenderizer

Orthomatics, Inc., Highlands Ranch CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K111249 is the FDA 510(k) clearance record for ORTHOSLENDERIZER, a class I device, cleared for Orthomatics, Inc. on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list one 510(k) clearance for Orthomatics, Inc. As of , FDA records show no recalls naming K111249.

Clearance record

Decision date
Received
(281 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Orthomatics, Inc. 200 W. County Line Rd. #340, Highlands Ranch CO
510(k) summary
Statement
Third party review
No

Clearances, product code EFB

Trailing 12 months
4 clearances under product code EFB in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EFB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20261