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Mastergraft Putty

by Medtronic Sofamor Danek, Inc. 2 variants

510(k) K081784

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081784 Date17 Sep 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LYC
FDA applicant
Medtronic Sofamor Danek
Device class
Class II
Regulation
21 CFR Part 872.3930
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Mastergraft Putty is a synthetic bone grafting material used as a bone void filler. It is designed to be combined with sterile water or autograft to fill bony voids, where it is resorbed and remodeled by the host bone during the healing process.

This device is authorized under FDA 510(k) clearance. It is intended for use in dental applications as a bone grafting material.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical use for Mastergraft Putty?

    Mastergraft Putty is indicated for use as a synthetic bone grafting material specifically for dental applications. It functions as a bone void filler to support the healing process.

  • How is Mastergraft Putty prepared for application?

    The putty is designed to be combined with either sterile water or autograft before being placed into the bony void. This preparation allows the material to be effectively applied to the surgical site.

  • What happens to the material after it is implanted?

    Once placed in the bony void, Mastergraft Putty is resorbed and remodeled by the host bone during the natural healing process.

  • What is the regulatory status of this device?

    Mastergraft Putty is authorized under FDA 510(k) clearance, which indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.