FDA.reportPublic FDA data

DOME Coronado Dental Delivery Unit

Primary DI
D1351480
Brand
DOME Coronado Dental Delivery Unit
Company
Dome, Inc.
Model
148
Catalog number
148
Device description
Dental delivery system instrument unit, pneumatic
Published
2025-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D1351480PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system instrument unit, pneumaticA pneumatically-powered device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height30Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Liquid Chemical

Contacts#

Phone, Email table
PhoneEmail
818-344-3404info@domeortho.com

Regulatory Flags#

DUNS number
053883807
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D1355370DOME Innovation Chair5375372025-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10371347017912Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017929Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017837Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017844Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017851Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017868Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
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