510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K073040Substantially Equivalent

Smh Flex S

Smh Biomaterial AG, Denton TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073040 is the FDA 510(k) clearance record for SMH FLEX S, a class II device, cleared for Smh Biomaterial AG on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list one 510(k) clearance for Smh Biomaterial AG. As of , FDA records show no recalls naming K073040.

Clearance record

Decision date
Received
(45 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Smh Biomaterial AG 3537 Teasley Ln., Denton TX
510(k) summary
Summary PDF
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