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Zoral Scaler Solution®

FDA UDI

Class I (US FDA UDI)

by Anodia Systems

Identity

Trade Name
Zoral Scaler Solution® FDA UDI
Generic Name
Dental scaling solution FDA UDI
Device Name
Lubricating Coolant Irrigating Solution used with Dental Irrigation Systems and Ultrasonic Scalers During Dental Hygiene Scaling Procedures. 1 Bottle Package (ITEM #MAK-Z1) FDA UDI
Model / Reference
MAK-Z1 FDA UDI
Description
Lubricating Coolant Irrigating Solution used with Dental Irrigation Systems and Ultrasonic Scalers During Dental Hygiene Scaling Procedures. 1 Bottle Package (ITEM #MAK-Z1) FDA UDI

Identifiers

Primary DI / UDI-DI
00854542008198 FDA UDI
510(k) Number
K925378 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Dental scaling solution FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental scaling solution

Zoral Scaler Solution® by Anodia Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental scaling solution.

Cleared under the same submission

K925378 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anodia Systems

Sources (1)

  • FDA UDI 7f7a5138-f997-427c-9075-387120d04f40 35 fields · synced May 30, 2026