Cleared Traditional

K133507 - GUIDOSS

K133507 is an FDA 510(k) clearance for GUIDOSS, manufactured by Nibec Co., Ltd.. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K133507 · Nibec Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
356d
Days
Class 2
Risk

K133507 is an FDA 510(k) clearance for the GUIDOSS. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Nibec Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on November 5, 2014 after a review of 356 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: 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 Nibec Co., Ltd. devices

FDA 510(k) Submission Details - K133507

510(k) Number K133507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2013
Decision Date November 05, 2014
Days to Decision 356 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 127d · This submission: 356d
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 36
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K133507.
Geistlich Fibro-Gide
K171050 · Geistlich Pharma AG · Nov 2017
Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
K171643 · Geistlich Pharma AG · Oct 2017
Collagen Dental Membrane - Conformable IIBP
K142496 · Collagen Matrix, Inc. · Nov 2014
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP
K141909 · Collagen Matrix, Inc. · Nov 2014
GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
K140518 · Geistlich Pharma AG · Jul 2014
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
K110600 · Collagen Matrix, Inc. · Jul 2011