Cleared Traditional

K203282 - TECHFIT Patient-Specific Maxillofacial ...

K203282 is an FDA 510(k) clearance for TECHFIT Patient-Specific Maxillofacial ..., manufactured by Industrias Medicas Sampedro S.A.S. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K203282 · Industrias Medicas Sampedro S.A.S · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
194d
Days
Class 2
Risk

K203282 is an FDA 510(k) clearance for the TECHFIT Patient-Specific Maxillofacial System. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Industrias Medicas Sampedro S.A.S (La Estrella, CO). The FDA issued a Cleared decision on May 19, 2021 after a review of 194 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 Industrias Medicas Sampedro S.A.S devices

FDA 510(k) Submission Details - K203282

510(k) Number K203282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2020
Decision Date May 19, 2021
Days to Decision 194 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
67d slower than avg
Panel avg: 127d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 193
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