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510(k) K780804

HYGIENIC ANCHORINGS by Hygienic Dental Mfg., Co., The — Product Code ECI

K780804 is an FDA 510(k) premarket notification submitted by Hygienic Dental Mfg., Co., The for the device "HYGIENIC ANCHORINGS". The FDA issued a decision of Substantially Equivalent on June 14, 1978. The device falls under product code ECI (Band, Elastic, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Hygienic Dental Mfg., Co., The has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1978
Date Received
May 11, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Band, Elastic, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

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

  • K780745 — RUBBER DAM (May 12, 1978)
  • K780743 — CLAMP FORCEPS (May 12, 1978)
  • K780744 — BRINKER TISSUE RETRACTORS (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 ECI

  • K980864 — POWER COINS GLOW IN THE DARK LIGATURES (April 20, 1998)
  • K980053 — GLENROE CHAIN (February 24, 1998)
  • K973495 — GLENROE GLOW IN DARK ELASTOMERIC LIGATURES (December 1, 1997)
  • K943419 — ORTHODONTIC ELASTOMERIC LAGATURE MODULE (May 24, 1995)
  • K943417 — ORTHODONTIC ELASTOMERIC TUBE/THREAD (May 23, 1995)
  • K943418 — ORTHODONTIC ELASTOMERIC SEPARATOR MODULE (May 23, 1995)
  • K943420 — ORTHODONTIC ELASTOMERIC CHAIN (May 23, 1995)
  • K940165 — ALASTIK (March 7, 1994)
  • K932298 — PRO'S NEO-LASTICS (February 14, 1994)
  • K935144 — DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS (February 4, 1994)

FDA data resources