Cleared Traditional

K030052 - OSTIM (FDA 510(k) Clearance)

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

K030052 · Heraeus Kulzer, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
700d
Days
Class 2
Risk

K030052 is an FDA 510(k) clearance for the OSTIM. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on December 6, 2004 after a review of 700 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K030052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2003
Decision Date December 06, 2004
Days to Decision 700 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
573d slower than avg
Panel avg: 127d · This submission: 700d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - LYC Bone Grafting Material, Synthetic

All 228
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K030052.
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