Cleared Traditional

K042583 - CALC-I-OSS

K042583 is an FDA 510(k) clearance for CALC-I-OSS, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K042583 · Ultradent Products, Inc. · Dental device
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Jul 2005
Decision
300d
Days
Class 2
Risk

K042583 is an FDA 510(k) clearance for the CALC-I-OSS. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 19, 2005 after a review of 300 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K042583

510(k) Number K042583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2004
Decision Date July 19, 2005
Days to Decision 300 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
173d slower than avg
Panel avg: 127d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYC Device Classification - Class 2, Special Controls

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 149
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K042583.
SYNTHOGRAFT
K051091 · Bicon, Inc. · Sep 2005
FORTOSS VITAL BONE GRAFT SUBSTITUTE
K050170 · Biocomposites, Ltd. · Aug 2005
BIOPLANT
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BIORESORB MACRO PORE
K050260 · Oraltronics Dental Implant Technology GmbH · Jul 2005
ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
K051381 · Ace Surgical Supply Co., Inc. · Jul 2005
CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G
K042730 · Lifecorebiomedical · Feb 2005