← Back to catalogue

Frontier Dental by 3D Dental Design

FDA UDI

Class II (US FDA UDI)

by 3d Dental Designs And Development, Llc

Identity

Trade Name
Frontier Dental by 3D Dental Design FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
Biological Integrator Pouch of 500 FDA UDI
Model / Reference
Z-BI FDA UDI
Description
Biological Integrator Pouch of 500 FDA UDI

Identifiers

Primary DI / UDI-DI
00817169022053 FDA UDI
FDA Product Code
JOJ FDA UDI
GMDN Term
Chemical/physical sterilization process indicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Chemical/physical sterilization process indicator

Frontier Dental by 3D Dental Design by 3d Dental Designs And Development, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chemical/physical sterilization process indicator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
3d Dental Designs And Development, Llc

Sources (1)

  • FDA UDI 5a56ff37-4268-402e-9d3d-fb5083dabb0b 33 fields · synced May 30, 2026