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
K812709Substantially Equivalent

Sterile Dental Roll

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

K812709 is the FDA 510(k) clearance record for STERILE DENTAL ROLL, a class I device, cleared for Medspec Corp. on under FDA product code EFN (Cotton, Roll). FDA records list 15 510(k) clearances for Medspec Corp., from to . As of , FDA records show no recalls naming K812709.

Clearance record

Decision date
Received
(29 days to decision)
Product code
EFN Cotton, Roll
Regulation
21 CFR 872.6050
Device class
Class I
Review panel
Dental
Applicant
Medspec Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EFN

Trailing 12 months

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

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