Cleared Traditional

K811101 - HYDROXYLAPATITE

K811101 is an FDA 510(k) clearance for HYDROXYLAPATITE, manufactured by Carbomedics, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K811101 · Carbomedics, Inc. · Dental device
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Nov 1981
Decision
213d
Days
Class 2
Risk

K811101 is an FDA 510(k) clearance for the HYDROXYLAPATITE. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Carbomedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1981 after a review of 213 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. 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 Carbomedics, Inc. devices

FDA 510(k) Submission Details - K811101

510(k) Number K811101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1981
Decision Date November 20, 1981
Days to Decision 213 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 127d · This submission: 213d
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 75
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K811101.
ANTERIOR ALVEOLAR RIDGE SIZER
K843153 · Interpore Intl. · Sep 1984
POROUS HYDROXYAPATITE BG200
K841201 · Interpore Intl. · Aug 1984
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
K821752 · Depuy, Inc. · Aug 1982
HYDROXYLAPATITE ALVEOLAR RIDGE MAIN
K810382 · Carbomedics, Inc. · Mar 1981
PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT
K791416 · Carbomedics, Inc. · Oct 1979