510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K990763Substantially Equivalent

Vitron M

Espe Dental AG, Bavaria D-82228 Seefeld, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990763 is the FDA 510(k) clearance record for VITRON M, a class II device, cleared for Espe Dental AG on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 29 510(k) clearances for Espe Dental AG, from to . As of , FDA records show no recalls naming K990763.

Clearance record

Decision date
Received
(78 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Espe Dental AG Espe Platz, Bavaria D-82228 Seefeld, DE
510(k) summary
Summary
Third party review
No

Clearances, product code EBI

Trailing 12 months
10 clearances under product code EBI in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
November 20253
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260