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the Wand Handpiece

FDA UDI

Class II (US FDA UDI)

by Milestone Scientific, Inc.

Identity

Trade Name
the Wand Handpiece FDA UDI
Generic Name
Dental computer assisted anaesthesia injection handpiece FDA UDI
Device Name
WA Handpiece with needle FDA UDI
Model / Reference
WA-2050-305 FDA UDI
Description
WA Handpiece with needle FDA UDI

Identifiers

Primary DI / UDI-DI
20618874000138 FDA UDI
510(k) Number
K961648 FDA UDI
FDA Product Code
EJI FDA UDI
GMDN Term
Dental computer assisted anaesthesia injection handpiece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6770 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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 computer assisted anaesthesia injection handpiece

the Wand Handpiece by Milestone Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental computer assisted anaesthesia injection handpiece.

Cleared under the same submission

K961648 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Milestone Scientific, Inc.

Sources (1)

  • FDA UDI 78b3b9ac-ee75-4c69-ae99-c7ab30df3120 34 fields · synced Jun 8, 2026