Atlantis(Tm) Abutment and Atlantis(Tm) Crown Abutment for Keystone Genesis Implant, Atlantis Gemini(Tm) Abutment...

FDA 510(k) K113003 · Astra Tech, Inc.

Substantially Equivalent

510(k) numberK113003

Submission

Device name
Atlantis(Tm) Abutment and Atlantis(Tm) Crown Abutment for Keystone Genesis Implant, Atlantis Gemini(Tm) Abutment...
Applicant
Astra Tech, Inc.
Skokie, IL, US
Received
October 7, 2011
Decision date
March 1, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 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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K122078Lofric Primo, Lofric Hydro-KitEZD · Traditional 10/31/2012SE
K120414Osseospeed PlusDZE · Traditional 07/31/2012SE
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
K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantNHA · Traditional 12/01/2011SE
K111287Astra Tech Implant SystemDZE · Traditional 09/26/2011SE
K101005Astra Tech Implant System, New ComponentNHA · Special 06/21/2011SE
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 Atlantis(Tm) Abutment and Atlantis(Tm) Crown Abutment for Keystone Genesis Implant, Atlantis Gemini(Tm) Abutment... cleared by the FDA?

Atlantis(Tm) Abutment and Atlantis(Tm) Crown Abutment for Keystone Genesis Implant, Atlantis Gemini(Tm) Abutment... (K113003) received a 510(k) decision of Substantially Equivalent on March 1, 2012, 146 days after the submission was received.

What is the product code of K113003?

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