Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit

FDA 510(k) K142890 · Straumann USA, LLC

Substantially Equivalent

510(k) numberK142890

Submission

Device name
Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit
Applicant
Straumann USA, LLC
Andover, MA, US
Received
October 3, 2014
Decision date
January 9, 2015
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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K192401Straumann Screw-Retained AbutmentsNHA · Traditional 04/06/2020SE
K190662MRI Compatibility for Existing Straumann Dental Implant SystemsDZE · Traditional 06/17/2019SE
K171784Straumann Dental Implant SystemDZE · Traditional 01/19/2018SE
K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…DZE · Traditional 03/08/2017SE
K151590Straumann RN Gold Abutment for BridgeNHA · Traditional 03/04/2016SE
K151328PURE Ceramic ImplantsDZE · Traditional 01/11/2016SE
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Questions and answers

When was Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit cleared by the FDA?

Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit (K142890) received a 510(k) decision of Substantially Equivalent on January 9, 2015, 98 days after the submission was received.

What is the product code of K142890?

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