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DD Bio Splint P HI

FDA UDI

Class U (US FDA UDI)

by Dental Direkt GmbH

Identity

Trade Name
DD Bio Splint 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 Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months. FDA UDI
Model / Reference
98H20 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 Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months. FDA UDI

Identifiers

Catalog Number
K40120 FDA UDI
Primary DI / UDI-DI
EDDIK401201 FDA UDI
FDA Product Code
MQC FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
U 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 — 20 Millimeter FDA UDI
Outer Diameter — 98.5 Millimeter FDA UDI

Category: Dental appliance fabrication material, thermoplastic

DD Bio Splint P HI by Dental Direkt GmbH — Class U — 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 be1bf1f4-6972-4cce-88c1-d76ed99c9ebd 36 fields · synced May 31, 2026