Cleared Traditional

K233954 - Chemi-SiL (HB, MB, LB, LBS) (FDA 510(k) Clearance)

Also includes:
Chemi-SiL Bite-Blu

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

K233954 · B&E Korea Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
60d
Days
Class 2
Risk

K233954 is an FDA 510(k) clearance for the Chemi-SiL (HB, MB, LB, LBS). Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by B&E Korea Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on February 13, 2024 after a review of 60 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 B&E Korea Co., Ltd. devices

Submission Details

510(k) Number K233954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2023
Decision Date February 13, 2024
Days to Decision 60 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 faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - ELW Material, Impression

All 401
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