Home / 510(k) Clearances / K760980

510(k) K760980

DENTAL ALLOY by Adp Intl., Inc. — Product Code EJJ

K760980 is an FDA 510(k) premarket notification submitted by Adp Intl., Inc. for the device "DENTAL ALLOY". The FDA issued a decision of Substantially Equivalent on November 15, 1976. The device falls under product code EJJ (Alloy, Amalgam), a Class II device regulated under 21 CFR 872.3070. Adp Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1976
Date Received
October 21, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Amalgam
Device Class
Class II
Regulation Number
872.3070
Review Panel
DE
Submission Type

Other clearances by Adp Intl., Inc.

  • K760986 — CARBIDE DENTAL BURS (November 15, 1976)
  • K760988 — DENTAL HANDPIECES (November 15, 1976)
  • K760978 — ZINC CEMENT (November 15, 1976)
  • K760979 — COMPOSITE MATERIAL (November 15, 1976)
  • K760987 — DIAMOND STONES (November 15, 1976)
  • K760985 — HAND INSTRUMENTS (November 15, 1976)
  • K760981 — ALGINATE IMPRESSION MATERIAL (November 15, 1976)
  • K760983 — ENDODONTIC INSTRUMENTS (November 15, 1976)
  • K760982 — DENTAL VARNISH (November 15, 1976)
  • K760984 — ORTHODONTIC INSTRUMENTS (November 15, 1976)

Other clearances for product code EJJ

  • K053114 — SILVERFIL (November 15, 2005)
  • K051010 — SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 (May 2, 2005)
  • K033434 — BESTALOY (November 12, 2003)
  • K032152 — BENCO ADMIX (August 6, 2003)
  • K031658 — BENCO SPHERICAL (July 29, 2003)
  • K020452 — HIGH SILVER CONVENTIONAL (May 7, 2002)
  • K011801 — FUTURA TOPCAP NON GAMMA-2 (August 16, 2001)
  • K002811 — ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY (October 31, 2000)
  • K002810 — ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY (October 31, 2000)
  • K002808 — ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY (October 31, 2000)

FDA data resources