Cleared Traditional

K121318 - PROSOFT

K121318 is an FDA 510(k) clearance for PROSOFT, manufactured by Perma Laboratories. The device is a Class 2 Dental device with product code EBP cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K121318 · Perma Laboratories · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
35d
Days
Class 2
Risk

K121318 is an FDA 510(k) clearance for the PROSOFT. Classified as Reliner, Denture, Over The Counter (product code EBP), Class II - Special Controls.

Submitted by Perma Laboratories (Hinckley, US). The FDA issued a Cleared decision on June 6, 2012 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3560 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K121318

510(k) Number K121318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2012
Decision Date June 06, 2012
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 128d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EBP Device Classification - Class 2, Special Controls

Product Code EBP Reliner, Denture, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3560
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

K121318 · PROSOFT
Download PDF FDA Summary Perma Laboratories