FDA.reportPublic FDA data

Dentalez

Primary DI
D06036553570
Brand
Dentalez
Company
Dentalez Alabama, Inc.
Model
3655357
Device description
CORE CMU MOUNTED UNIT
Published
2024-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K931204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931204000AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM)Den-Tal-Ez Mfg Co., Inc.1993-07-08EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D06036553570PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery systemA stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806326521
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D06035441770Dentalez35441772024-11-05
D06035441780Dentalez35441782024-11-05
D06035441790Dentalez35441792024-11-05
D06035441870Dentalez35441872024-11-05
D06035441880Dentalez35441882024-11-05
D06035441900Dentalez35441902024-11-05
D06035441910Dentalez35441912024-11-05
D06035441920Dentalez35441922024-11-05
D06035441930Dentalez35441932024-11-05
D06035441940Dentalez35441942024-11-05
D06035442070Dentalez35442072024-11-05
D06035442080Dentalez35442082024-11-05
D06035442150Dentalez35442152024-11-05
D06035442160Dentalez35442162024-11-05
D06035442170Dentalez35442172024-11-05
D06035442340Dentalez35442342024-11-05
D06035442370Dentalez35442372024-11-05
D06035442380Dentalez35442382024-11-05
D06035442390Dentalez35442392024-11-05
D06035442400Dentalez35442402024-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
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50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
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J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
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