510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K901697Substantially Equivalent

Silistor Ceramic and Resin Repair System

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

K901697 is the FDA 510(k) clearance record for SILISTOR CERAMIC AND RESIN REPAIR SYSTEM, a class II device, cleared for Kulzer, Inc. on under FDA product code EBF (Material, Tooth Shade, Resin). FDA records list 205 510(k) clearances for Kulzer, Inc., from to . As of , FDA records show no recalls naming K901697.

Clearance record

Decision date
Received
(66 days to decision)
Product code
EBF Material, Tooth Shade, Resin
Regulation
21 CFR 872.3690
Device class
Class II
Review panel
Dental
Applicant
Kulzer, Inc. 680 N. Lake Shore Dr., Chicago IL
Third party review
No

Clearances, product code EBF

Trailing 12 months
18 clearances under product code EBF in the twelve months to November 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code EBF, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20262
April 20265
May 20262
June 20262
July 20262
August 20261
September 20262
October 20260
November 20260