510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K031701Substantially Equivalent

Osteomed Temporary Condylar Attachment System

Osteomed, Addison TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031701 is the FDA 510(k) clearance record for OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM, a class II device, cleared for Osteomed LP on under FDA product code NEI (Prosthesis, Condyle, Mandibular, Temporary). FDA records list 73 510(k) clearances for Osteomed LP, from to . As of , FDA records show no recalls naming K031701.

Clearance record

Decision date
Received
(402 days to decision)
Product code
NEI Prosthesis, Condyle, Mandibular, Temporary
Regulation
21 CFR 872.4770
Device class
Class II
Review panel
Dental
Applicant
Osteomed LP 3885 Arapaho Rd., Addison TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEI

Trailing 12 months

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

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