Harvard PremiumFill Kit A1 +5 more models

FDA UDI

Class II (US FDA UDI)

by Harvard Dental International GmbH

Identity

Trade Name: Harvard PremiumFill Kit A1; A2; A3; A3,5; B2; A2opaque, Incisal FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Universal light cure nano-hybrid composite for restorations. The kit contains different shades of Harvard PremiumFill. FDA UDI
Model / Reference: 7082210 FDA UDI
Description: Universal light cure nano-hybrid composite for restorations. The kit contains different shades of Harvard PremiumFill. FDA UDI

Identifiers

Primary DI / UDI-DI: EHAR70822101 FDA UDI
FDA Product Code: EBF FDA UDI
GMDN Term: Dental composite resin FDA UDI
Models / Variants: Harvard PremiumFill Kit A1 FDA UDI
A2 FDA UDI
A3 FDA UDI
A3, 5 FDA UDI
B2 FDA UDI
A2opaque, Incisal FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Dental composite resin

Harvard PremiumFill Kit A1 +5 more models by Harvard Dental International GmbH — Class II — FDA UDI — listed in FDA GUDID — 6 models

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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 II	Pending data

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Manufacturer

Manufacturer: Harvard Dental International GmbH

Sources (1)

FDA UDI 71140d05-10c7-427f-ace0-4ba5c10087e0 35 fields · synced May 30, 2026