Cleared Traditional

GUIDOR(TM) (K912724) - FDA 510(k) Clearance

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

K912724 · Procordia Oratech AB · Dental device
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May 1993
Decision
695d
Days
Class 2
Risk

K912724 is an FDA 510(k) clearance for the GUIDOR(TM). Classified as Barrier, Synthetic, Intraoral (product code NPK), Class II - Special Controls.

Submitted by Procordia Oratech AB (Huddinge, Sweden, SE). The FDA issued a Cleared decision on May 13, 1993 after a review of 695 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 Procordia Oratech AB devices

Submission Details

510(k) Number K912724 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 18, 1991
Decision Date May 13, 1993
Days to Decision 695 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
568d slower than avg
Panel avg: 127d · This submission: 695d
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 11
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K912724.
GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
K960292 · W.L. Gore & Associates, Inc. · Apr 1996
GORE-TEX REGENERATIVE MATERIAL
K922627 · W.L. Gore & Associates, Inc. · Jun 1994
GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS
K933541 · W.L. Gore & Associates, Inc. · Nov 1993
GORE-TEX PERIODONTAL MATERIAL
K854299 · W.L. Gore & Associates, Inc. · May 1986