Cleared Traditional

K211812 - BLUEDIAMOND IMPLANT

K211812 is the FDA 510(k) clearance for BLUEDIAMOND IMPLANT by Megagen Implant Co., Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 574-day FDA review.

K211812 · Megagen Implant Co., Ltd. · Dental device
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Jan 2023
Decision
574d
Days
Class 2
Risk

K211812 is an FDA 510(k) clearance for the BLUEDIAMOND IMPLANT, Abutment Screw. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Megagen Implant Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on January 6, 2023 after a review of 574 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 Megagen Implant Co., Ltd. devices

Submission Details

510(k) Number K211812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2021
Decision Date January 06, 2023
Days to Decision 574 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
447d slower than avg
Panel avg: 127d · This submission: 574d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 598
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