Home / 510(k) Clearances / K780744

510(k) K780744

BRINKER TISSUE RETRACTORS by Hygienic Dental Mfg., Co., The — Product Code EEF

K780744 is an FDA 510(k) premarket notification submitted by Hygienic Dental Mfg., Co., The for the device "BRINKER TISSUE RETRACTORS". The FDA issued a decision of Substantially Equivalent on May 12, 1978. The device falls under product code EEF (Clamp, Rubber Dam), a Class I device regulated under 21 CFR 872.6300. Hygienic Dental Mfg., Co., The has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1978
Date Received
April 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Rubber Dam
Device Class
Class I
Regulation Number
872.6300
Review Panel
DE
Submission Type

Other clearances by Hygienic Dental Mfg., Co., The

  • K780804 — HYGIENIC ANCHORINGS (June 14, 1978)
  • K780745 — RUBBER DAM (May 12, 1978)
  • K780743 — CLAMP FORCEPS (May 12, 1978)
  • K780746 — HYGIENIC RUBBER DAM FRAME (May 12, 1978)
  • K770117 — HYGIENIC 5 & 6 RUBBER DAM FRAME (January 28, 1977)

Other clearances for product code EEF

  • K071615 — FIXAFLOSS (September 21, 2007)
  • K915207 — DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP (February 14, 1992)

FDA data resources