Cleared Traditional

K210797 - Bio-MEM Ti Reinforced Membrane (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210797 · B&Medi Co., Ltd. · Dental device
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Aug 2022
Decision
520d
Days
Class 2
Risk

K210797 is an FDA 510(k) clearance for the Bio-MEM Ti Reinforced Membrane. Classified as Barrier, Synthetic, Intraoral (product code NPK), Class II - Special Controls.

Submitted by B&Medi Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on August 18, 2022 after a review of 520 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - 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 B&Medi Co., Ltd. devices

Submission Details

510(k) Number K210797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2021
Decision Date August 18, 2022
Days to Decision 520 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
393d slower than avg
Panel avg: 127d · This submission: 520d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NPK Barrier, Synthetic, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Dental Barrier Is A Synthetic Material Device, Such As Ptfe, Intended To Aid In Guided Tissue And/or Bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials.
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 - NPK Barrier, Synthetic, Intraoral

All 30
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K210797.
Lumina-PTFE Titanium
K221851 · Criteria Industria E Comercio DE Produtos Medicinais · Dec 2023
OpenTex
K222549 · Purgo Biologics, Inc. · May 2023
InnoGenic Non-resorbable Membrane
K211554 · Cowellmedi Co., Ltd. · Feb 2023
Cytoplast Titanium-Reinforced PTFE Membranes
K201187 · Osteogenics Biomedical, Inc. · Jan 2021