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Hexa

FDA UDI

Class I (US FDA UDI)

by Hexa Dental

Identity

Trade Name
HEXA FDA UDI
Generic Name
Dental polishing cup, single-use FDA UDI
Device Name
Hexa Prophy Paste Splatter-Free Containing 1.23% Fluoride (Medium) Assorted , 200/Pk FDA UDI
Model / Reference
HPP-2004 FDA UDI
Description
Hexa Prophy Paste Splatter-Free Containing 1.23% Fluoride (Medium) Assorted , 200/Pk FDA UDI

Identifiers

Catalog Number
HPP-2001 FDA UDI
Primary DI / UDI-DI
00850023750297 FDA UDI
FDA Product Code
EHK FDA UDI
GMDN Term
Dental polishing cup, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6290 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

Yes

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 polishing cup, single-use

Hexa by Hexa Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental polishing cup, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hexa Dental

Sources (1)

  • FDA UDI 95c9d1f3-1699-44cb-8196-0f30f85f0c63 35 fields · synced May 30, 2026