Cleared Traditional

K230091 - THE Cover

K230091 is an FDA 510(k) clearance for THE Cover, manufactured by Purgo Biologics, Inc.. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K230091 · Purgo Biologics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
267d
Days
Class 2
Risk

K230091 is an FDA 510(k) clearance for the THE Cover. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Purgo Biologics, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on October 6, 2023 after a review of 267 days - an extended review cycle.

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: 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 Purgo Biologics, Inc. devices

FDA 510(k) Submission Details - K230091

510(k) Number K230091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2023
Decision Date October 06, 2023
Days to Decision 267 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
140d slower than avg
Panel avg: 127d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPL Device Classification - Class 2, Special Controls

Product Code NPL Barrier, Animal Source, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants.
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 - NPL Barrier, Animal Source, Intraoral

All 32
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K230091.
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