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Solidex

FDA UDI

Class II (US FDA UDI)

by Creodent Hudson Valley

Identity

Trade Name
Solidex FDA UDI
Generic Name
Dental implant suprastructure, permanent, custom-made FDA UDI
Device Name
10mm Blank Compatible with Nobel Biocare Active NP Implant Platform FDA UDI
Model / Reference
ACT35BL FDA UDI
Description
10mm Blank Compatible with Nobel Biocare Active NP Implant Platform FDA UDI

Identifiers

Primary DI / UDI-DI
D124ACT35BL0 FDA UDI
510(k) Number
K113738 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, permanent, custom-made FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Dental implant suprastructure, permanent, custom-made

Solidex by Creodent Hudson Valley — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant suprastructure, permanent, custom-made.

Cleared under the same submission

K113738 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Creodent Hudson Valley

Sources (1)

  • FDA UDI 193a9029-97c7-4578-9367-294b72f4b966 34 fields · synced May 30, 2026