Home / 510(k) Clearances / K895462

510(k) K895462

OSSEODENT DENTAL ATTACHMENTS by Collagen Corp. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1990
Date Received
September 6, 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)
  • K895463 — OSSEODENT(R) PRECISION DENTAL ATTACHMENTS (March 28, 1990)
  • K894331 — OSSEODENT SURGICAL KIT (October 4, 1989)
  • K883322 — DENTAL HAND INSTRUMENTS (August 26, 1988)
  • K812617 — VITROGEN TM 100 (October 2, 1981)

Other clearances for product code DZE

  • K252168 — Straumann® BLC Implants - Indication Widening (March 10, 2026)
  • K253493 — Dentis SQ-SL AXEL Fixture (March 4, 2026)
  • K252197 — Nobel Biocare S Series Implants (February 18, 2026)
  • K252286 — BIORES Dental Implant System (February 2, 2026)
  • K252585 — ZENEX Implant System_R-System (January 8, 2026)
  • K250476 — NizPlant Dental Implant System (December 23, 2025)
  • K252145 — GEN5™ and GEN5+™ 3.3mmD Dental Implants (December 23, 2025)
  • K251605 — DIMPLO Implant System (December 22, 2025)
  • K252090 — Pterygoid Indication for GM Helix Implants (December 12, 2025)
  • K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System (November 7, 2025)