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BioPure

FDA UDI

Class U (US FDA UDI)

by Tulsa Dental Products Llc

Identity

Trade Name
BioPure FDA UDI
Generic Name
Root canal cleaning solution FDA UDI
Device Name
BioPure MTAD Starter Sys Endo FDA UDI
Model / Reference
BPSYRNDL2 FDA UDI
Description
BioPure MTAD Starter Sys Endo FDA UDI

Identifiers

Catalog Number
BP156SYS FDA UDI
Primary DI / UDI-DI
D716BP156SYS1 FDA UDI
FDA Product Code
KJJ FDA UDI
GMDN Term
Root canal cleaning solution 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

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: Root canal cleaning solution

BioPure by Tulsa Dental Products Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Root canal cleaning solution.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 8723e148-be02-4b90-969a-2941eab4f304 34 fields · synced May 31, 2026