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510(k) K771399

LIP & CHEEK RETRACTOR by L.D. Caulk Co. — Product Code EIG

K771399 is an FDA 510(k) premarket notification submitted by L.D. Caulk Co. for the device "LIP & CHEEK RETRACTOR". The FDA issued a decision of Substantially Equivalent on August 26, 1977. The device falls under product code EIG (Retractor, All Types), a Class I device regulated under 21 CFR 872.4565. L.D. Caulk Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1977
Date Received
July 29, 1977
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 L.D. Caulk Co.

  • K802262 — COMPOSITE RESTORATIVE (September 16, 1980)
  • K801690 — VALIANT (August 13, 1980)
  • K790585 — FINESSE (May 16, 1979)
  • K790586 — CHEMBOND (May 16, 1979)
  • K780560 — DENTAL AMALGAMATOR (April 21, 1978)
  • K780384 — IMPROVED DYCAL (March 15, 1978)
  • K780301 — CAULK TYLOK (February 28, 1978)
  • K771398 — SHELL VENEER (August 26, 1977)
  • K771402 — NUVA-COTE (MODIFICATION TO) (August 26, 1977)
  • K771401 — PROPHY PASTE (August 22, 1977)

Other clearances for product code EIG

  • K971284 — OPALDAM (June 3, 1997)
  • 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)
  • K761024 — RACESTYPTINE RINGS (November 19, 1976)
  • K760657 — RACESTYPTINE CORD (September 27, 1976)

FDA data resources