510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062130Substantially Equivalent

Meisinger Benex, Model Be001

Hager & Meisinger GmbH, Centennial CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K062130 is the FDA 510(k) clearance record for MEISINGER BENEX, MODEL BE001, a class I device, cleared for Hager& Meisinger GmbH on under FDA product code EMG (Forceps, Tooth Extractor, Surgical). FDA records list 14 510(k) clearances for Hager& Meisinger GmbH, from to . As of , FDA records show no recalls naming K062130.

Clearance record

Decision date
Received
(264 days to decision)
Product code
EMG Forceps, Tooth Extractor, Surgical
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Hager& Meisinger GmbH 7442 S. Tucson Way, Suite 130, Centennial CO
510(k) summary
Statement
Third party review
No

Clearances, product code EMG

Trailing 12 months

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

FDA records show no clearances under product code EMG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EMG, 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