FDA.reportPublic FDA data

DentaPure Water Purification Bottle Cartridge

Primary DI
50732224005671
Brand
DentaPure Water Purification Bottle Cartridge
Company
CROSSTEX INTERNATIONAL, INC.
Model
DPI365B10
Device description
International Water Purification Bottle Cartridge
Published
2024-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EIAUnit, operative dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992893000DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGEMrlb Intl., Inc.1999-09-08EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50732224005671PrimaryGS10
00732224005676Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222400567150732224005671
00732224005676007322240056767322240056760732224005676

GMDN Terms#

Term, Definition table
TermDefinition
Dental waterline disinfectant cartridgeA device in the form of a cartridge containing a disinfectant (e.g., iodine resin) intended to be integrated within a dental waterline (i.e., water fed to certain dental instruments) to maintain disinfection of the water prior to patient contact through introduction of the disinfectant. This is a disposable device not intended to be reprocessed, which has a multiple-patient use application (reusable).

Regulatory Flags#

DUNS number
057728685
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10732224002993Bite Wing-Ease™ Barrier SleevesBWES2022-09-29
10732224003044Slip-Ease™ CushionsBWSEL2022-09-29
10732224003068Wrap-Ease™ CushionsBWWEL2022-09-29
10732224003549Advantage Plus Cotton Tipped ApplicatorsH3AC2022-08-19
10732224003556Advantage Plus Cotton Tipped ApplicatorsH6AC2022-08-19
10732224120499Surgical Tie-On MaskGCS2022-05-06
50732224001291Polyback™ TowelsWPXFP2022-10-31
50732224001321Polyback™ TowelsWPXTB2022-10-31
50732224002359Econoback™ TowelsWEXFP2022-10-31
50732224002366Econoback™ TowelsWEXTB2022-10-31
50732224003936Non-Woven Headrest coversL3CB2022-09-29
50732224004841Professional Regular TowelsWTXFPWTXFP2023-07-17
30732224001136Self-Sealing Sterilization BagOCS2022-05-03
50732224005206Premium Non-Woven SpongesENCNW4KENCNW4K2025-10-23
50732224001086Ultra Gauze Non-Woven SpongesENCNWUBENCNWUB2025-10-23
10732224001088Ultra Gauze Non-Woven SpongesENCNWUBENCNWUB2022-08-25
10732224005208Premium Non-Woven SpongesENCNW4KENCNW4K2023-07-17
50732224000140Sani Vac Evacuation System CleanerJVACSAMPLESJVACSAMPLES2022-08-19
10732224110568Duo-Check Self-Sealing Sterilization PouchesSCM2025-07-24
10732224000050Crosstex InternationalSCMSCM2016-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975659690060YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690077YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690107YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690114YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-07
00841709109805MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109812MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109843MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109850MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109874MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109881MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110030MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110054MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110061MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111846MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111853MidmarkMIDMARK CORPORATIONEIA2026-09-28
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
00850043433521E300 Delivery SystemEngle Dental Systems, LLCEIA2026-02-09
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-09-04
00850043433514E300 Dr./Asst Rear DeliveryEngle Dental Systems, LLCEIA2025-08-26
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
00850043433507Cabinet Side Mt Rear Delivery Asst OnlyEngle Dental Systems, LLCEIA2024-11-06
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
00850043433484E2 360 Delivery SystemEngle Dental Systems, LLCEIA2023-12-14
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11