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Nacera Pearl Shaded 16+2 24x24x24 C1

by Dental Direkt GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEDDI32713024241 UDI-DI Date28 May 2024ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Nacera Pearl Shaded 16+2
Generic Name
Dental appliance fabrication material, ceramic
Model / Ref / Catalog
24x24x24 C1, 3271302424
Primary DI / UDI-DI
EDDI32713024241
510(k) Number
FDA Product Code
EIH
GMDN Term
Dental appliance fabrication material, ceramic
Device Class
Class II
Regulation Number
872.6660
GUDID distribution status
In Commercial Distribution
Size
Length — 24 Millimeter
Height — 24 Millimeter
Width — 24 Millimeter

Related devices

Category: Dental appliance fabrication material, ceramic

Cleared under the same submission (K143071)

Show all (12)

Other devices from Dental Direkt GmbH

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No