510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913688Substantially Equivalent

Bud Maxillofacial Implant System

Bud Industries, Inc., Holland NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913688 is the FDA 510(k) clearance record for BUD MAXILLOFACIAL IMPLANT SYSTEM, a class II device, cleared for Bud Industries, Inc. on under FDA product code JEY (Plate, Bone). FDA records list 3 510(k) clearances for Bud Industries, Inc., from to . As of , FDA records show no recalls naming K913688.

Clearance record

Decision date
Received
(260 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Bud Industries, Inc. P.O. Box 1, Holland NY
510(k) summary
Statement
Third party review
No

Clearances, product code JEY

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