DentaPure Dental Unit Water Purification Cartridge

FDA UDIEUDAMED

Class I (US FDA UDI)

by Crosstex International, Inc.

Identity

Trade Name: DentaPure Dental Unit Water Purification Cartridge FDA UDI
Generic Name: Dental waterline disinfectant cartridge FDA UDI
Device Name: 60 day independent water filter FDA UDI
Model / Reference: DP40B FDA UDI
Description: 60 day independent water filter FDA UDI

Identifiers

Catalog Number: DP40B FDA UDI
Primary DI / UDI-DI: 10732224005529 FDA UDI
510(k) Number: K992868 FDA UDI
FDA Product Code: EIA FDA UDI
GMDN Term: Dental waterline disinfectant cartridge FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6640 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental waterline disinfectant cartridge

DentaPure Dental Unit Water Purification Cartridge by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

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Also classified as Dental waterline disinfectant cartridge.

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Cleared under the same submission

K992868 also covers:

DentaPure Water Purification Bottle Cartridge — CROSSTEX INTERNATIONAL, INC.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Crosstex International, Inc.

Sources (2)

FDA UDI 042b42a8-d220-44f6-81e7-ce14037319de 36 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 2, 2026