Cleared Traditional

K210499 - Alpha Dent Implants Dental Implants System

K210499 is an FDA 510(k) clearance for Alpha Dent Implants Dental Implants System, manufactured by Alpha Dent Implants GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K210499 · Alpha Dent Implants GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
252d
Days
Class 2
Risk

K210499 is an FDA 510(k) clearance for the Alpha Dent Implants Dental Implants System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Alpha Dent Implants GmbH (Pforzheim, DE). The FDA issued a Cleared decision on November 1, 2021 after a review of 252 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Alpha Dent Implants GmbH devices

FDA 510(k) Submission Details - K210499

510(k) Number K210499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2021
Decision Date November 01, 2021
Days to Decision 252 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
125d slower than avg
Panel avg: 127d · This submission: 252d
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 758
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K210499.
N1 TiUltra TCC Implant System
K211109 · Nobel Biocare Services AG · Dec 2021
DESS Dental Implants
K212538 · Terrats Medical SL · Dec 2021
Paltop Narrow Implant
K210117 · Paltop Advanced Dental Solutions, Ltd. · Nov 2021
S.I.N. Dental Implant System
K211921 · S.I.N. ? Sistema DE Implante Nacional S.A. · Oct 2021
Magicore System
K212517 · Innobiosurg Co., Ltd. · Oct 2021
Implanova
K210523 · Dental Evolutions, Inc. · Sep 2021