Cleared Traditional

K212364 - BLT Dental Implant System

K212364 is an FDA 510(k) clearance for BLT Dental Implant System, manufactured by Bio Concept Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 376-day FDA review.

K212364 · Bio Concept Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
376d
Days
Class 2
Risk

K212364 is an FDA 510(k) clearance for the BLT Dental Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Bio Concept Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on August 10, 2022 after a review of 376 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Bio Concept Co., Ltd. devices

FDA 510(k) Submission Details - K212364

510(k) Number K212364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2021
Decision Date August 10, 2022
Days to Decision 376 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
249d slower than avg
Panel avg: 127d · This submission: 376d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K212364.
NB 1 SA Implant System
K222131 · Arum Dentistry Co., Ltd. · Sep 2022
TSX Implants
K220978 · Biomet 3i, LLC · Sep 2022
Neodent Implant System - GM Narrow Implant System
K220251 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Sep 2022
BTI Interna Narrow/Plus Dental Implant System UnicCa
K211952 · B.T.I. Biotechnology Institute, Sl. · Jul 2022
Tatum Surgical Dental Implant System
K213576 · Suncoast Dental, Inc. Dba Tatum Surgical · Jul 2022
Kontact Dental Implant System
K213997 · Biotech Dental, Sas · Jul 2022