Home / 510(k) Clearances / K812709

510(k) K812709

STERILE DENTAL ROLL by Medspec Corp. — Product Code EFN

K812709 is an FDA 510(k) premarket notification submitted by Medspec Corp. for the device "STERILE DENTAL ROLL". The FDA issued a decision of Substantially Equivalent on October 23, 1981. The device falls under product code EFN (Cotton, Roll), a Class I device regulated under 21 CFR 872.6050. Medspec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1981
Date Received
September 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cotton, Roll
Device Class
Class I
Regulation Number
872.6050
Review Panel
DE
Submission Type

Other clearances by Medspec Corp.

  • K813012 — STERILE BASIN SETS (November 6, 1981)
  • K812710 — STERILE LAPAROTOMY SPONGES-X-RAY DETECT (November 2, 1981)
  • K812707 — STERILE DISSECTOR SPONGES-X-RAY DETECT (November 2, 1981)
  • K812711 — STERILE GAUZE PADS 12PLY (November 2, 1981)
  • K810071 — STERILE SILICONE TUBING (February 12, 1981)
  • K810069 — STERILE AIRWAY (February 2, 1981)
  • K802060 — STERILE TONSIL SPONGES (October 10, 1980)
  • K801069 — STERILE ISOLATION GOWN (May 20, 1980)
  • K801068 — STERILE ABDOMINAL PAD (May 20, 1980)
  • K800278 — MEDSPEC SAFETY PINS (May 2, 1980)

Other clearances for product code EFN

  • K872810 — STRUNG DENTAL ROLLS (December 4, 1987)
  • K871464 — MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER (April 30, 1987)
  • K863764 — COTTON ROLLS, NON-STERILE (October 27, 1986)
  • K861338 — DENTAL COTTON ROLLS, STERILE AND NON-STERILE (August 6, 1986)
  • K861727 — COTTON FILLED GAUZE SPONGES 2 X 2 (July 10, 1986)
  • K843539 — TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- (May 23, 1985)
  • K841327 — DENTAL COTTON ROLLS (July 3, 1984)
  • K834056 — SCHEIN COTTON ROLLS, NON-STERILE (February 3, 1984)
  • K830175 — STERILE COTTON ROLLS #3, 1 1/2 (February 18, 1983)
  • K810830 — HOYT COTTON ROLLS (April 14, 1981)

FDA data resources