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Henry Schein

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
Dental composite resin FDA UDI
Device Name
Natural Elegance Syringe FDA UDI
Model / Reference
9000998 FDA UDI
Description
Natural Elegance Syringe FDA UDI

Identifiers

Catalog Number
9000998 FDA UDI
Primary DI / UDI-DI
00304040004616 FDA UDI
FDA Product Code
DYH FDA UDI
EBF FDA UDI
GMDN Term
Dental composite resin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3750 FDA UDI
872.3690 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

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

No

FDA UDI

Dimensions & Sizes

Size
Weight — 4.5 Gram FDA UDI

Category: Dental composite resin

Henry Schein's Natural Elegance Syringe is a high-quality dental composite resin device designed for professional use. This syringe contains a non-sterile substance intended as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material. Preloaded into a dedicated disposable device, it cannot be reused after application.

Similar devices

Also classified as Dental composite resin.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI 28496a19-e5c1-42ff-ad43-5852a0f5d814 36 fields · synced Jul 24, 2026