Inlay / Onlay Styx

FDA UDI

Class I (US FDA UDI)

by Taub Products

Identity

Trade Name: Inlay / Onlay Styx FDA UDI
Generic Name: Manual non-rotary dental instrument handle FDA UDI
Device Name: Prevents movement of the restoration during cementation. Allows for proper placement, positioning, and seating of inlays, onlays, crowns, with gentle and even distribution of pressure. Holds restoration securely during try-in, while contacts are checked with floss. Allows clear visibility of working field. Removes the need for touching the restoration with a glove. This prevents possible contamination of saliva or glove powder. Inlay/Onlay Styx are autoclavable. Tips are disposable (Single use per patient). FDA UDI
Model / Reference: TIPS 12 pk - Inlay / Onlay Styx White FDA UDI
Description: Prevents movement of the restoration during cementation. Allows for proper placement, positioning, and seating of inlays, onlays, crowns, with gentle and even distribution of pressure. Holds restoration securely during try-in, while contacts are checked with floss. Allows clear visibility of working field. Removes the need for touching the restoration with a glove. This prevents possible contamination of saliva or glove powder. Inlay/Onlay Styx are autoclavable. Tips are disposable (Single use per patient). FDA UDI

Identifiers

Catalog Number: 45-2020 FDA UDI
Primary DI / UDI-DI: D8374520200 FDA UDI
FDA Product Code: DZN FDA UDI
GMDN Term: Manual non-rotary dental instrument handle FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual non-rotary dental instrument handle

Inlay / Onlay Styx by Taub Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Manual non-rotary dental instrument handle.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Taub Products

Sources (1)

FDA UDI 38397bee-909d-44e8-ad6b-d953b14ec3b0 34 fields · synced Jun 8, 2026