FDA.reportPublic FDA data

DentaPure Dental Unit Water Purification Cartridge

Primary DI
10732224005529
Brand
DentaPure Dental Unit Water Purification Cartridge
Company
CROSSTEX INTERNATIONAL, INC.
Model
DP40B
Catalog number
DP40B
Device description
60 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
K992868000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992868000DENTAPURE DP40 CARTRIDGEMrlb Intl., Inc.1999-09-07EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50732224005527PrimaryGS10
10732224005529Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5073222400552750732224005527
1073222400552910732224005529

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

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Primary DI, Brand, Company table
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