Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3

FDA 510(k) K030682 · Bioform, Inc.

Substantially Equivalent

510(k) numberK030682

Submission

Device name
Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3
Applicant
Bioform, Inc.
Franksville, WI, US
Received
March 5, 2003
Decision date
June 27, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LYC – Bone Grafting Material, Synthetic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3930
Specialty
Dental
Implant
Yes

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.

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Questions and answers

When was Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3 cleared by the FDA?

Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3 (K030682) received a 510(k) decision of Substantially Equivalent on June 27, 2003, 114 days after the submission was received.

What is the product code of K030682?

The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.