510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130647Substantially Equivalent

Xantasil Dynamix Fast Set Cartridge -2 X 380Ml; Xantasil Fast Set Cartridge -6 X 50Ml

Kulzer GmbH, South Bend IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130647 is the FDA 510(k) clearance record for XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML, a class II device, cleared for Heraeus Kulzer, LLC on under FDA product code ELW (Material, Impression). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K130647.

Clearance record

Decision date
Received
(67 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Heraeus Kulzer, LLC 300 Heraeus Way, South Bend IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ELW

Trailing 12 months
3 clearances under product code ELW in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ELW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20262
October 20260