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Iceram-P Mbt 0.022 Kit – 5 Sets + 1 Free Mixed Orthodontic Mannequin

FDA UDI

Class II (US FDA UDI)

by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda

Identity

Trade Name
ICERAM-P MBT 0.022 KIT – 5 SETS + 1 FREE MIXED ORTHODONTIC MANNEQUIN FDA UDI
Generic Name
Orthodontic bracket, ceramic FDA UDI
Device Name
ICERAM-P MBT 0.022 5 SETS 1 FREE MIXED ORTHODONTIC MANNEQUIM FDA UDI
Model / Reference
10.93.2930 FDA UDI
Description
ICERAM-P MBT 0.022 5 SETS 1 FREE MIXED ORTHODONTIC MANNEQUIM FDA UDI

Identifiers

Primary DI / UDI-DI
07908611210340 FDA UDI
510(k) Number
K222847 FDA UDI
FDA Product Code
NJM FDA UDI
GMDN Term
Orthodontic bracket, ceramic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5470 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic bracket, ceramic

Iceram-P Mbt 0.022 Kit – 5 Sets + 1 Free Mixed Orthodontic Mannequin by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda — Class II…

Similar devices

Also classified as Orthodontic bracket, ceramic.

Cleared under the same submission

K222847 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda

Sources (1)

  • FDA UDI ef06d5a5-dd3d-462c-b6f8-38ebb6e603cc 34 fields · synced Jun 1, 2026