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ZirBlock

by Cdl Technologies, Inc.

510(k) K070537

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 NumberK070537 Date30 Apr 2007ClearedStatusActive

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  • Withdrawn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.

The ZirBlock is a dental device classified as a Zirconia Block for Dental Prosthetics (Product Code: EIH). It is a high-strength, ceramic material designed for milling and fabrication of dental restorations, including crowns, bridges, and inlays, offering durability and biocompatibility for long-term oral use.

ZirBlock is supplied as a solid zirconia block for dental laboratories and is intended for single-use in milling machines. The material requires no sterilisation prior to use and is compatible with standard dental milling protocols. It is regulated under the FDA’s 510(k) clearance (K070537) as a Class II dental device, meeting substantial equivalence to predicate devices under 21 CFR 872.6660. Blocks are available in standard dimensions as specified in the manufacturer’s milling guidelines.

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 is the ZirBlock used for in dental prosthetics?

    The ZirBlock is a zirconia block designed specifically for milling and fabricating dental restorations such as crowns, bridges, and inlays. Its high-strength ceramic material ensures durability and long-term biocompatibility in oral environments, making it ideal for precise and reliable dental prosthetics.

  • How is the ZirBlock supplied and intended for use?

    The ZirBlock is supplied as a solid zirconia block intended for single-use in dental milling machines within laboratories. It is pre-sterilized and does not require additional sterilization before use, simplifying workflows for dental technicians.

  • Is the ZirBlock reusable or single-use?

    The ZirBlock is designed for single-use only. This ensures consistency in material properties and reduces the risk of contamination or degradation from repeated milling processes, maintaining the integrity of dental restorations.

  • What are the standard dimensions or sizes available for the ZirBlock?

    The ZirBlock comes in standard dimensions as outlined in the manufacturer’s milling guidelines. While exact sizes are not specified here, these dimensions are optimized for compatibility with common dental milling machines to facilitate precise fabrication of restorations.

  • How should the ZirBlock be stored before use?

    The ZirBlock should be stored in a clean, dry environment protected from moisture, dust, and physical damage. Proper storage ensures the material remains intact and ready for milling, maintaining its structural integrity and performance.