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510(k) K912435

DENTAL CONNECTOR PRECISION ATTACHMENT by Metalor Dental USA Corp. — Product Code EGG

K912435 is an FDA 510(k) premarket notification submitted by Metalor Dental USA Corp. for the device "DENTAL CONNECTOR PRECISION ATTACHMENT". The FDA issued a decision of Substantially Equivalent on August 28, 1991. The device falls under product code EGG (Attachment, Precision, All), a Class I device regulated under 21 CFR 872.3165. Metalor Dental USA Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1991
Date Received
June 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Precision, All
Device Class
Class I
Regulation Number
872.3165
Review Panel
DE
Submission Type

Other clearances by Metalor Dental USA Corp.

  • K003387 — AUROFILM NP (January 9, 2001)
  • K993475 — AUROFLUID M, ALLOY NO. 5315 (December 9, 1999)
  • K993505 — V-DELTA SPECIAL, ALLOY NO. 5154 (December 8, 1999)
  • K993506 — PAGALINOR 4 , ALLOY NO. 5440 (December 8, 1999)
  • K993508 — V-SUPRA PLUS, ALLOY NO. 5025 (December 6, 1999)
  • K993507 — V-SUPRAGOLD, ALLOY NO. 5024 (December 6, 1999)
  • K993474 — DELTAPAL, ALLOY NO. 5161 (December 2, 1999)
  • K982606 — AUROFLUID CPF (October 15, 1998)
  • K973372 — AUROFILM 2000 (November 26, 1997)
  • K972683 — V-DELTA 450 (August 18, 1997)

Other clearances for product code EGG

  • K990979 — STECO-TITANMAGNETICS (September 3, 1999)
  • K950259 — COUPLING DEVICE FOR DENTAL PROSTHESIS (December 6, 1996)
  • K925700 — ZEST ANCHOR ADVANCED GENERATION (April 7, 1994)
  • K915299 — COGAN CORP KITS OF DENTAL HAND INSTRUMENTS (January 31, 1992)
  • K912567 — CONICAST, INTRACAST, OMECAST (July 2, 1991)
  • K901928 — INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH (July 26, 1990)
  • K900785 — MICRO 2 SYSTEM (April 16, 1990)
  • K896337 — DENTAL BRIDGE ANCHORING PINS (January 31, 1990)
  • K895986 — PRECISION DENTAL ATTACHMENTS (October 18, 1989)
  • K891119 — T.R.S.: TOOTH REPLACEMENT SYSTEM (April 17, 1989)

FDA data resources