Cleared Traditional

Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw

K231100 · Proimtech Saglik Urunleri Anonim Sirketi · Dental

Aug 2024

Decision

493d

Days

Class 2

Risk

About This 510(k) Submission

K231100 is an FDA 510(k) clearance for the Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Proimtech Saglik Urunleri Anonim Sirketi (Istanbul, TR). The FDA issued a Cleared decision on August 23, 2024, 493 days after receiving the submission on April 18, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K231100 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2023
Decision Date	August 23, 2024
Days to Decision	493 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF