Cleared Special

K253883 - Bonalive Maxillofacial (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253883 · Bonalive , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
161d
Days
Class 2
Risk

K253883 is an FDA 510(k) clearance for the Bonalive Maxillofacial. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Bonalive , Ltd. (Turku, FI). The FDA issued a Cleared decision on May 14, 2026 after a review of 161 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bonalive , Ltd. devices

Submission Details

510(k) Number K253883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2025
Decision Date May 14, 2026
Days to Decision 161 days
Submission Type Special
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
34d slower than avg
Panel avg: 127d · This submission: 161d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LYC Bone Grafting Material, Synthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw.
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

Obelix Consulting
Elisa Maldonado-Holmertz

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 - LYC Bone Grafting Material, Synthetic

All 229
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K253883.
BONTREE PLUS
K251818 · Hudens Bio Co., Ltd. · Mar 2026
FG Bone Graft M
K244006 · Full Golden Biotech Co., Ltd. · Sep 2025
FG Bone Graft B
K243745 · Full Golden Biotech Corporation · Aug 2025
Synthetic Bone Graft Particulate
K241186 · Shenzhen Dazhou Medical Technology Co., Ltd. · Feb 2025
CMFlexTM
K213260 · Dimension Inx Corp. · Dec 2022
InRoad® Dental Synthetic Bone Graft
K202675 · Osteogene Tech Corp · Mar 2022