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510(k) K990458

STRAUMANN EXTRAORAL IMPLANT SYSTEM by Straumann USA — Product Code KCZ

K990458 is an FDA 510(k) premarket notification submitted by Straumann USA for the device "STRAUMANN EXTRAORAL IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on April 16, 1999. The device falls under product code KCZ (Prosthesis, Breast, External, Used With Adhesive), a Class I device regulated under 21 CFR 878.3800. Straumann USA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1999
Date Received
February 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Breast, External, Used With Adhesive
Device Class
Class I
Regulation Number
878.3800
Review Panel
SU
Submission Type

Other clearances by Straumann USA

  • K241575 — Straumann® Anatomic Healing Abutments XC (AHA) (November 11, 2024)
  • K203753 — Straumann Surgical Cassettes (July 29, 2021)
  • K202942 — Straumann 4 mm Short Implants (February 8, 2021)
  • K192401 — Straumann Screw-Retained Abutments (April 6, 2020)
  • K190662 — MRI Compatibility for Existing Straumann Dental Implant Systems (June 17, 2019)
  • K171784 — Straumann Dental Implant System (January 19, 2018)
  • K162890 — BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments (March 8, 2017)
  • K151590 — Straumann RN Gold Abutment for Bridge (March 4, 2016)
  • K151328 — PURE Ceramic Implants (January 11, 2016)
  • K150899 — Straumann CARES Titanium Alloy (TAN) Abutment (September 16, 2015)

Other clearances for product code KCZ

  • K951324 — MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS (May 26, 1995)
  • K933465 — COSMET (July 20, 1994)
  • K932978 — CALSSIQUE OR MYSTIQUE (December 22, 1993)
  • K932899 — CLASSIQUE (December 16, 1993)
  • K933668 — ALMOST U, INC. BREAST PROSTHESIS (December 10, 1993)
  • K921535 — SUOENA AFFINITY (TM) MODEL #802 (May 11, 1992)
  • K915382 — AMOENA AFFINITY MODEL #802 (January 14, 1992)
  • K911247 — YOURS TRULY ASYMMETRICAL BREAST FORM (March 29, 1991)
  • K904085 — ELLA BREAST FORM (October 31, 1990)
  • K904316 — NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT (October 11, 1990)

FDA data resources