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Periophil B-TCP

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093871

by Cytophil, Inc.

Identifiers

510(k) Number
K093871 FDA 510(k)
FDA Product Code
LYC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3930 FDA 510(k)
Regulation Number
872.3930 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Periophil B-TCP is a synthetic bone grafting material classified as a Bone Grafting Material, Synthetic. It is composed of beta-tricalcium phosphate (β-TCP) and designed to fill, augment, or reconstruct periodontal or oral/maxillofacial defects, including osseous defects created surgically or through traumatic injury. The material features a multidirectional interconnected porosity structure, mimicking human cancellous bone to support bone regeneration and remodeling.

This device is supplied as a sterile, single-use material and is intended for use in dental procedures. It is classified as a Class II medical device under FDA product code LYC and has received FDA 510(k) clearance. Periophil B-TCP is non-magnetic and safe for use in non-MRI environments. Storage conditions and regulatory compliance are governed by the manufacturer’s specifications, ensuring proper handling and application in clinical settings.

Frequently asked questions

What types of dental defects is Periophil B-TCP specifically designed to address and how does its structure support bone regeneration?

Periophil B-TCP is designed to fill, augment, or reconstruct periodontal and oral/maxillofacial defects, including osseous defects created surgically or through traumatic injury. Its multidirectional interconnected porosity mimics human cancellous bone, which promotes bone regeneration and remodeling by providing a scaffold for new bone growth.

Is Periophil B-TCP safe for use in patients who require MRI scans, and what storage conditions should be followed?

Periophil B-TCP is explicitly labeled as non-magnetic, making it safe for use in non-MRI environments. Storage conditions are governed by the manufacturer’s specifications, which ensure proper handling and preservation of sterility, though exact details must be referenced directly from Cytophil, Inc.

How is Periophil B-TCP supplied, and is it reusable or intended for single-use only?

Periophil B-TCP is supplied as a sterile, single-use material, meaning each package is intended for one surgical procedure only. This design ensures patient safety and maintains sterility standards.

What regulatory pathway was followed for FDA clearance, and what does the product code LYC indicate about its classification?

Periophil B-TCP received FDA 510(k) clearance through a traditional review pathway, determined to be substantially equivalent to a predicate device. The product code LYC classifies it as a Bone Grafting Material, Synthetic, under FDA’s Class II medical device regulations, indicating it undergoes additional controls beyond general controls.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: periophil b-tcp - Cytophil | FDA Evidence Review, PERIOPHIL B-TCP by CYTOPHIL INC | FDA 510 (k) Summary, PERIOPHIL B-TCP (K093871) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cytophil, Inc.

Sources (1)

  • FDA 510(k) K093871 24 fields · synced Sep 19, 2026