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510(k) K894331

OSSEODENT SURGICAL KIT by Collagen Corp. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1989
Date Received
July 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by Collagen Corp.

  • K904671 — QAR HANDPIECE (December 21, 1990)
  • K904228 — OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED) (November 9, 1990)
  • K901600 — OSSEOTITE IRRIGATION UNIT (June 21, 1990)
  • K900275 — OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNET (April 19, 1990)
  • K895462 — OSSEODENT DENTAL ATTACHMENTS (April 4, 1990)
  • K895463 — OSSEODENT(R) PRECISION DENTAL ATTACHMENTS (March 28, 1990)
  • K883322 — DENTAL HAND INSTRUMENTS (August 26, 1988)
  • K812617 — VITROGEN TM 100 (October 2, 1981)

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