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
K781345Substantially Equivalent

Ultrafill- Ultrabound

Demetron Research Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781345 is the FDA 510(k) clearance record for ULTRAFILL- ULTRABOUND, a class II device, cleared for Demetron Research Corp. on under FDA product code EBD (Coating, Filling Material, Resin). FDA records list 4 510(k) clearances for Demetron Research Corp., from to . As of , FDA records show no recalls naming K781345.

Clearance record

Decision date
Received
(24 days to decision)
Product code
EBD Coating, Filling Material, Resin
Regulation
21 CFR 872.3310
Device class
Class II
Review panel
Dental
Applicant
Demetron Research Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EBD

Trailing 12 months
1 clearance under product code EBD in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260