OnX - Bleach

FDA UDI

Class II (US FDA UDI)

by Sprintray, Inc.

Identity

Trade Name: OnX - Bleach FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: Full arch provisional restoration for all-on-x cases. Denture teeth for removable permanent full dentures. FDA UDI
Model / Reference: SRI-0202021 FDA UDI
Description: Full arch provisional restoration for all-on-x cases. Denture teeth for removable permanent full dentures. FDA UDI

Identifiers

Catalog Number: SRI-0202021 FDA UDI
Primary DI / UDI-DI: 00850039704079 FDA UDI
FDA Product Code: PZY FDA UDI
ELM FDA UDI
ELK FDA UDI
ELJ FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3590 FDA UDI
872.3910 FDA UDI
872.3900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1 Liter FDA UDI

Category: Dental appliance fabrication material, resin

OnX - Bleach by Sprintray, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Sprintray, Inc.

Sources (1)

FDA UDI 88e2f24e-580d-411c-9a86-610f615b9ead 37 fields · synced Jun 1, 2026