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510(k) K971284

OPALDAM by Ultradent Products, Inc. — Product Code EIG

K971284 is an FDA 510(k) premarket notification submitted by Ultradent Products, Inc. for the device "OPALDAM". The FDA issued a decision of Substantially Equivalent on June 3, 1997. The device falls under product code EIG (Retractor, All Types), a Class I device regulated under 21 CFR 872.4565. Ultradent Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1997
Date Received
April 7, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, All Types
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Ultradent Products, Inc.

  • K262228 — Transcend Bulk Fill Flowable Composite (July 1, 2026)
  • K261404 — UltraEZ (April 30, 2026)
  • K240743 — Peak Universal Bond (March 20, 2024)
  • K240694 — FORMA Composite (Shade A3D) (March 15, 2024)
  • K221909 — J-Temp (July 1, 2022)
  • K220471 — VALO X, VALO X Accessory Lenses (February 22, 2022)
  • K211905 — UltraCal XS (October 13, 2021)
  • K211237 — UltraTemp Rez II (July 13, 2021)
  • K210550 — VALO Grand Corded and Accessory Lenses (March 1, 2021)
  • K190627 — VALO Grand Corded (April 29, 2019)

Other clearances for product code EIG

  • K854711 — FIBRELIGHT ILLUMINATING ORAL RETRACTORS (February 25, 1986)
  • K832366 — ZOLLER BURNED LIP CONFORMER (September 26, 1983)
  • K821784 — BEACH GINGIVAL RETRACTION INSTR. TYPE B (July 6, 1982)
  • K771973 — GINGITRACT (November 7, 1977)
  • K771399 — LIP & CHEEK RETRACTOR (August 26, 1977)
  • K761024 — RACESTYPTINE RINGS (November 19, 1976)
  • K760657 — RACESTYPTINE CORD (September 27, 1976)

FDA data resources