Straumann BLX Line Extension - New Abutments

FDA 510(k) K190040 · Institut Straumann AG

Substantially Equivalent

510(k) numberK190040

Submission

Device name
Straumann BLX Line Extension - New Abutments
Applicant
Institut Straumann AG
Basel, CH
Received
January 8, 2019
Decision date
April 8, 2019
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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Questions and answers

When was Straumann BLX Line Extension - New Abutments cleared by the FDA?

Straumann BLX Line Extension - New Abutments (K190040) received a 510(k) decision of Substantially Equivalent on April 8, 2019, 90 days after the submission was received.

What is the product code of K190040?

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