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510(k) K780560

DENTAL AMALGAMATOR by L.D. Caulk Co. — Product Code EFD

K780560 is an FDA 510(k) premarket notification submitted by L.D. Caulk Co. for the device "DENTAL AMALGAMATOR". The FDA issued a decision of Substantially Equivalent on April 21, 1978. The device falls under product code EFD (Amalgamator, Dental, Ac-Powered), a Class I device regulated under 21 CFR 872.3100. L.D. Caulk Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1978
Date Received
April 5, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amalgamator, Dental, Ac-Powered
Device Class
Class I
Regulation Number
872.3100
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)
  • K780384 — IMPROVED DYCAL (March 15, 1978)
  • K780301 — CAULK TYLOK (February 28, 1978)
  • K771402 — NUVA-COTE (MODIFICATION TO) (August 26, 1977)
  • K771398 — SHELL VENEER (August 26, 1977)
  • K771399 — LIP & CHEEK RETRACTOR (August 26, 1977)
  • K771403 — EASE (MODIFICATION TO) (August 22, 1977)

Other clearances for product code EFD

  • K991913 — PENTAMIX 2 (July 26, 1999)
  • K923974 — SILIMAT PLUS (October 6, 1992)
  • K922203 — IPT CAPSULE MIXER (June 3, 1992)
  • K915847 — AUTOMIX DENTAL AMALGAMATOR (March 2, 1992)
  • K914340 — DUOMAT 3 AMALGAMATOR (November 13, 1991)
  • K914341 — MIXOMAT AMALGAMATOR (November 13, 1991)
  • K914339 — DENTOMAT 3 AMALGAMATORS (November 7, 1991)
  • K910632 — ACCU-MIX AMALGAMATOR (March 15, 1991)
  • K901909 — SILAMAT (AMALGAMATOR) (June 22, 1990)
  • K891612 — DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. (June 12, 1989)

FDA data resources