FDA.reportPublic FDA data

DentaPure Dental Unit Water Purification Cartridge

Primary DI
10732224005505
Brand
DentaPure Dental Unit Water Purification Cartridge
Company
CROSSTEX INTERNATIONAL, INC.
Model
DP365B
Catalog number
DP365B
Device description
365 day independent water filter
Published
2023-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
50732224005503PrimaryGS10
10732224005505Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5073222400550350732224005503
1073222400550510732224005505

GMDN Terms#

Term, Definition table
TermDefinition
Legionella water purification filter, non-sterileA non-sterile device intended to remove Legionella bacteria from flowing water to reduce the risk of Legionella contamination during body washing for hygiene; it is not intended for medical washing/irrigation and is not intended for general microbial filtration. It typically consists of a plastic housing with a connector attached to the water source [e.g., a tap (faucet)] and a filtering membrane [e.g., made of polyethersulfone (PES)]; it may include a distal shower rose/directing nozzle. This is a disposable device not intended to be reprocessed, which has a multiple-patient use application (reusable).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(585)359-0167regulatoryaffairs@hu-friedy.com
1-585-359-0130regulatoryaffairs@hu-friedy.com
+1(585)359-0130regulatoryaffairs@hu-friedy.com

Regulatory Flags#

DUNS number
057728685
Device count
1
DM exempt
true
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
03760278267754ACTEONSOPROEIA2026-10-21
06975220031162Dental UnitLakong Medical Devices Co., Ltd.EIA2026-10-20
06975220031179Dental UnitLakong Medical Devices Co., Ltd.EIA2026-10-20
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