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Dento Prep

FDA UDI

Class II (US FDA UDI)

by Rønvig Dental Manufacturing A/S

Identity

Trade Name
DENTO PREP FDA UDI
Generic Name
Dental abrasive air jet system FDA UDI
Device Name
Dental Micro-blaster for use with aluminium oxide powder. FDA UDI
Model / Reference
1900 FDA UDI
Description
Dental Micro-blaster for use with aluminium oxide powder. FDA UDI

Identifiers

Primary DI / UDI-DI
05713513000164 FDA UDI
510(k) Number
K010816 FDA UDI
FDA Product Code
KOJ FDA UDI
GMDN Term
Dental abrasive air jet system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6080 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

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental abrasive air jet system

Dento Prep by Rønvig Dental Manufacturing A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental abrasive air jet system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rønvig Dental Manufacturing A/S

Sources (1)

  • FDA UDI 6ab89c06-e762-49c1-b6cf-2db6efdf643c 34 fields · synced May 30, 2026