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Hilla Digital Transfers

by Hilla Technologies, Inc.

510(k) K113575

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 NumberK113575 Date7 Mar 2012ClearedStatusActive

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  • Withdrawn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
EIH
Device Class
Class II
Regulation
21 CFR Part 872.6660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

Hilla Digital Transfers are colored ceramic stains supplied in a decal form for firing onto dental ceramic prosthetic devices. They consist of ceramic stain powders in decal form, providing an artistic and esthetic representation of incisal details present in natural teeth.

The device is used by dental technicians in a laboratory setting to eliminate the need for individual application of ceramic stain powders. It is supplied as a decal form of ceramic stains and is intended for use on dental ceramic prosthetic devices to provide esthetic incisal edge coloring.

Questions

AI-generated answers, 1 Oct 2026

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

  • What are Hilla Digital Transfers used for?

    Hilla Digital Transfers are used by dental technicians in a laboratory setting to apply esthetic incisal edge coloring to dental ceramic prosthetic devices, eliminating the need for individual application of ceramic stain powders.

  • How are Hilla Digital Transfers supplied?

    Hilla Digital Transfers are supplied as a decal form of ceramic stain powders, which are fired onto dental ceramic prosthetic devices during the manufacturing process.

  • Are Hilla Digital Transfers sterile or single-use?

    Hilla Digital Transfers are not described as sterile or single-use in the provided data; they are intended for use in a dental laboratory setting by technicians during the fabrication of prosthetic devices.