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DD base P HI

FDA UDI

Class II (US FDA UDI)

by Dental Direkt GmbH

Identity

Trade Name
DD base P HI FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems. DD base P HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures. DD base P HI is suitable for longterm use in the oral cavity up to 10 years. FDA UDI
Model / Reference
98H25 light pink FDA UDI
Description
DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems. DD base P HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures. DD base P HI is suitable for longterm use in the oral cavity up to 10 years. FDA UDI

Identifiers

Catalog Number
K50225 FDA UDI
Primary DI / UDI-DI
EDDIK502251 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 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

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 25 Millimeter FDA UDI
Outer Diameter — 98.5 Millimeter FDA UDI

Category: Dental appliance fabrication material, thermoplastic

DD base P HI by Dental Direkt GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dental Direkt GmbH

Sources (1)

  • FDA UDI 0d58b00b-984b-4868-bc03-52e7d6f3d833 36 fields · synced May 31, 2026