Perioglas - Bioglass Bone Graft Particulate

FDA 510(k) K962494 · Usbiomaterials Corp.

Substantially Equivalent

510(k) numberK962494

Submission

Device name
Perioglas - Bioglass Bone Graft Particulate
Applicant
Usbiomaterials Corp.
Alachua, FL, US
Received
June 26, 1996
Decision date
September 20, 1996
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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More from Institut Straumann AG

510(k)DeviceDecision
K024343Butler Gum Prophy Paste with NovaminEJR · Traditional 07/11/2003SE
K000149Novabone-Bioglass Bone Graft ParticulateLYC · Special 02/07/2000SE
K992416Perioglas- Bioglass Bone Graft ParticulateLYC · Traditional 10/15/1999SE
K930115PerioglassLYC · Traditional 11/04/1993SE

Questions and answers

When was Perioglas - Bioglass Bone Graft Particulate cleared by the FDA?

Perioglas - Bioglass Bone Graft Particulate (K962494) received a 510(k) decision of Substantially Equivalent on September 20, 1996, 86 days after the submission was received.

What is the product code of K962494?

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