Astra Tech Implant System, New Component

FDA 510(k) K101005 · Astra Tech AB

Substantially Equivalent

510(k) numberK101005

Submission

Device name
Astra Tech Implant System, New Component
Applicant
Astra Tech AB
San Diego, CA, US
Received
April 12, 2010
Decision date
June 21, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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More from Hiossen, Inc.

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K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaNHA · Traditional 07/05/2012SE
K113424Lofric Single Use Urinary CatheterEZD · Traditional 04/17/2012SE
K113003Atlantis(Tm) Abutment and Atlantis(Tm) Crown Abutment for Keystone Genesis Implant…NHA · Traditional 03/01/2012SE
K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantNHA · Traditional 12/01/2011SE
K111287Astra Tech Implant SystemDZE · Traditional 09/26/2011SE
K110640Atlantis Abutment for Camlog Implant, Duplicate Abutment, Later AbutmentNHA · Traditional 06/10/2011SE
K110356Atlantis Crown Abutment, Atlantis Gemini +(Tm) AbutmentNHA · Traditional 06/10/2011SE

Questions and answers

When was Astra Tech Implant System, New Component cleared by the FDA?

Astra Tech Implant System, New Component (K101005) received a 510(k) decision of Substantially Equivalent on June 21, 2011, 435 days after the submission was received.

What is the product code of K101005?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.