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510(k) K760379

DENTAL AMALGAM ALLOY (SPHERICAL II) by L.D. Caulk Co. — Product Code EJS

K760379 is an FDA 510(k) premarket notification submitted by L.D. Caulk Co. for the device "DENTAL AMALGAM ALLOY (SPHERICAL II)". The FDA issued a decision of Substantially Equivalent on August 23, 1976. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. L.D. Caulk Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1976
Date Received
August 5, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Other Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by L.D. Caulk Co.

  • K802262 — COMPOSITE RESTORATIVE (September 16, 1980)
  • K801690 — VALIANT (August 13, 1980)
  • K790586 — CHEMBOND (May 16, 1979)
  • K790585 — FINESSE (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)
  • K771399 — LIP & CHEEK RETRACTOR (August 26, 1977)
  • K771402 — NUVA-COTE (MODIFICATION TO) (August 26, 1977)

Other clearances for product code EJS

  • K041433 — BRIGHT GOLD XH (August 19, 2004)
  • K040436 — SIMIDUR SUPERIOR (March 5, 2004)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K022469 — ECO E4 (September 18, 2002)
  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020195 — SIMIDUR S1S (March 15, 2002)
  • K020192 — SIMIDUR S2 (March 15, 2002)
  • K020194 — SIMIDUR KF PLUS (March 15, 2002)
  • K014042 — D.SIGN 84 (February 22, 2002)
  • K013809 — D.SIGN 59 (February 7, 2002)

FDA data resources