510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101064Substantially Equivalent

Bredent Novo.lign a/ Bredent Novo.lign P

Bredent GmbH & Co. KG, Tuttlingen, Baden Wurttemberg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101064 is the FDA 510(k) clearance record for BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P, a class II device, cleared for Bredent GmbH & Co. KG on under FDA product code ELM (Denture, Plastic, Teeth). FDA records list 3 510(k) clearances for Bredent GmbH & Co. KG, from to . As of , FDA records show no recalls naming K101064.

Clearance record

Decision date
Received
(151 days to decision)
Product code
ELM Denture, Plastic, Teeth
Regulation
21 CFR 872.3590
Device class
Class II
Review panel
Dental
Applicant
Bredent GmbH & Co. KG Schwarzwaldstrasse 5, Tuttlingen, Baden Wurttemberg, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ELM

Trailing 12 months

FDA records hold no clearances under product code ELM in the trailing twelve months.

FDA records show no clearances under product code ELM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260