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DOME Coronado Dental Delivery Unit

FDA UDI

Class I (US FDA UDI)

by Dome Inc

Identity

Trade Name
DOME Coronado Dental Delivery Unit FDA UDI
Generic Name
Dental delivery system instrument unit, pneumatic FDA UDI
Device Name
Dental delivery system instrument unit, pneumatic FDA UDI
Model / Reference
148 FDA UDI
Description
Dental delivery system instrument unit, pneumatic FDA UDI

Identifiers

Catalog Number
148 FDA UDI
Primary DI / UDI-DI
D1351480 FDA UDI
FDA Product Code
NRD FDA UDI
GMDN Term
Dental delivery system instrument unit, pneumatic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Liquid Chemical FDA UDI

Dimensions & Sizes

Size
Height — 30 Inch FDA UDI

Category: Dental delivery system instrument unit, pneumatic

DOME Coronado Dental Delivery Unit by Dome Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental delivery system instrument unit, pneumatic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dome Inc

Sources (1)

  • FDA UDI 210643e2-cc36-4747-a8d5-811dd0224a9e 37 fields · synced May 31, 2026