Cleared Traditional

K231100 - Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw

K231100 is an FDA 510(k) clearance for Proimtech Dental Body Implant, manufactured by Proimtech Saglik Urunleri Anonim Sirketi. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 493-day FDA review.

K231100 · Proimtech Saglik Urunleri Anonim Sirketi · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
493d
Days
Class 2
Risk

K231100 is an FDA 510(k) clearance for the Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Pro.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Proimtech Saglik Urunleri Anonim Sirketi (Istanbul, TR). The FDA issued a Cleared decision on August 23, 2024 after a review of 493 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Proimtech Saglik Urunleri Anonim Sirketi devices

FDA 510(k) Submission Details - K231100

510(k) Number K231100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
365d slower than avg
Panel avg: 128d · This submission: 493d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1370
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K231100.
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