510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K093299Substantially Equivalent

Synthes Orthodontic Bone Anchor System

Synthes (USA) Products LLC, West Chester PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093299 is the FDA 510(k) clearance record for SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM, a class II device, cleared for Synthes (Usa) on under FDA product code OAT (Implant, Endosseous, Orthodontic). FDA's definition for product code OAT reads: "It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed". FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show no recalls naming K093299.

Clearance record

Decision date
Received
(421 days to decision)
Product code
OAT Implant, Endosseous, Orthodontic
Regulation
21 CFR 872.3640
Device class
Class II
Review panel
Dental
Applicant
Synthes (Usa) 1301 Goshen Pkwy., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAT

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