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Eledent

FDA UDI

Class II (US FDA UDI)

by Union Dental Sa

Identity

Trade Name
ELEDENT FDA UDI
Generic Name
Resin artificial teeth FDA UDI
Device Name
ELEDENT posterior Teeth Shade B4, Mould 31L low. FDA UDI
Model / Reference
POSTERIOR TEETH B4/31LI FDA UDI
Description
ELEDENT posterior Teeth Shade B4, Mould 31L low. FDA UDI

Identifiers

Catalog Number
M9B431LI FDA UDI
Primary DI / UDI-DI
08435288467306 FDA UDI
510(k) Number
K070591 FDA UDI
FDA Product Code
ELM FDA UDI
GMDN Term
Resin artificial teeth FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3590 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Resin artificial teeth

ELEDENT posterior Teeth Shade B4, Mould 31L low. ELEDENT is a high-quality, prefabricated resin artificial teeth designed for mounting on dentures. Our patented dental material is made from a polymer-based technology, offering excellent durability and flexibility. With a range of colors and sizes available, ELEDENT can be tailored to meet the specific needs of individual patients.

Similar devices

Also classified as Resin artificial teeth.

Cleared under the same submission

K070591 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Union Dental Sa

Sources (1)

  • FDA UDI f6c7b430-3505-4bd5-82a6-c19f397b3d11 35 fields · synced Jun 20, 2026