Cleared Traditional

K173318 - Rapid HB, Rapid LB, Rapid MB

K173318 is an FDA 510(k) clearance for Rapid HB, manufactured by 3M Deutschland GmbH. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K173318 · 3M Deutschland GmbH · Dental device
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Optimized for regulatory review, auditing and printing
Oct 2017
Decision
11d
Days
Class 2
Risk

K173318 is an FDA 510(k) clearance for the Rapid HB, Rapid LB, Rapid MB. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by 3M Deutschland GmbH (Seefeld, DE). The FDA issued a Cleared decision on October 31, 2017 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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.

View all 3M Deutschland GmbH devices

FDA 510(k) Submission Details - K173318

510(k) Number K173318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2017
Decision Date October 31, 2017
Days to Decision 11 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
117d faster than avg
Panel avg: 128d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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.

Regulatory Peers - ELW Material, Impression

All 342
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K173318.
AIM2
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