Who is the manufacturer of TBM SPONGE?

Biocoll Laboratories, Inc. submitted the Traditional clearance for TBM SPONGE (K960267).

What is the FDA product code for TBM SPONGE?

LYC. It is classified under 21 CFR 872.3930 as a Class 2 device in the Dental panel.

What is the regulatory pathway for TBM SPONGE?

510(k) clearance (submission type: Traditional).

TBM SPONGE

K960267 · Biocoll Laboratories, Inc. · LYC · Nov 5, 1996 · Dental

Device Facts

Record ID	K960267
Device Name	TBM SPONGE
Applicant	Biocoll Laboratories, Inc.
Product Code	LYC · Dental
Decision Date	Nov 5, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3930
Device Class	Class 2

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.