Cleared Traditional

K212765 - Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (FDA 510(k) Clearance)

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

K212765 · Bloomden Bioceramics (Hunan) Co., Ltd. · Dental device
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Nov 2021
Decision
76d
Days
Class 2
Risk

K212765 is an FDA 510(k) clearance for the Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Bloomden Bioceramics (Hunan) Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on November 15, 2021 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Bloomden Bioceramics (Hunan) Co., Ltd. devices

Submission Details

510(k) Number K212765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2021
Decision Date November 15, 2021
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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

Shenzhen Joyantech Consulting Co., Ltd.
Grace Liu

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 - EIH Powder, Porcelain

All 478
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