510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K903317Substantially Equivalent

Dentalon Plus

Kulzer GmbH, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903317 is the FDA 510(k) clearance record for DENTALON PLUS, a class II device, cleared for Kulzer, Inc. on under FDA product code EBG (Crown And Bridge, Temporary, Resin). FDA records list 205 510(k) clearances for Kulzer, Inc., from to . As of , FDA records show no recalls naming K903317.

Clearance record

Decision date
Received
(19 days to decision)
Product code
EBG Crown And Bridge, Temporary, Resin
Regulation
21 CFR 872.3770
Device class
Class II
Review panel
Dental
Applicant
Kulzer, Inc. 10005 Muirlands Blvd., Irvine CA
Third party review
No

Clearances, product code EBG

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