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510(k) K810830

HOYT COTTON ROLLS by Hoyt Laboratories — Product Code EFN

K810830 is an FDA 510(k) premarket notification submitted by Hoyt Laboratories for the device "HOYT COTTON ROLLS". The FDA issued a decision of Substantially Equivalent on April 14, 1981. The device falls under product code EFN (Cotton, Roll), a Class I device regulated under 21 CFR 872.6050. Hoyt Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1981
Date Received
March 25, 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 Hoyt Laboratories

  • K820738 — LUSTRALLOY (April 9, 1982)
  • K811154 — HOYT ECONO-TRAY (May 13, 1981)
  • K780834 — PREVI DENT PROPHYLAXIS MINT NDC (June 2, 1978)
  • K771881 — REPLICA BONDING AGENT (November 9, 1977)
  • K771883 — REPLICA ACID-ETCH (October 20, 1977)
  • K771882 — REPLICA DENTAL COMPOSITE-RADIOPAQUE (October 20, 1977)
  • K771880 — REPLICA DENTAL COMPOSIT (October 20, 1977)
  • K771184 — TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 (July 15, 1977)
  • K771185 — PERIODONTIC TOOTHBRUSH, #0126-0190-00 (July 15, 1977)
  • K771183 — TOOTHBRUSH, PEDODONTIC, #0126-0188-00 (July 15, 1977)

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)
  • K812709 — STERILE DENTAL ROLL (October 23, 1981)

FDA data resources