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Orthocryl®

FDA UDI

Class I (US FDA UDI)

by Dentaurum

Identity

Trade Name
Orthocryl® FDA UDI
Generic Name
Orthodontic palate expander/teeth aligner, self-removable FDA UDI
Device Name
Orthocryl® EQ powder, clear/ orthodontic acrylics FDA UDI
Model / Reference
160-301-00 FDA UDI
Description
Orthocryl® EQ powder, clear/ orthodontic acrylics FDA UDI

Identifiers

Primary DI / UDI-DI
J011160301000 FDA UDI
510(k) Number
K942667 FDA UDI
FDA Product Code
KMY FDA UDI
GMDN Term
Orthodontic palate expander/teeth aligner, self-removable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5525 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

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthodontic palate expander/teeth aligner, self-removable

Orthocryl® by Dentaurum — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic palate expander/teeth aligner, self-removable.

Cleared under the same submission

K942667 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentaurum

Sources (1)

  • FDA UDI 8518ae28-f507-45ce-bac5-852dd83fcbf4 36 fields · synced Jun 1, 2026