SCOTT'S HANDHELD AUTOMIX CORE 2/pk BLUE

FDA UDI

Class II (US FDA UDI)

by Scott's Dental Supply L.l.c.

Identity

Trade Name: SCOTT'S HANDHELD AUTOMIX CORE 2/pk BLUE FDA UDI
Generic Name: Dental composite resin FDA UDI
Model / Reference: 199-3065 FDA UDI

Identifiers

Catalog Number: 199-3065 FDA UDI
Primary DI / UDI-DI: D77819930651 FDA UDI
510(k) Number: K022675 FDA UDI
FDA Product Code: EBF FDA UDI
GMDN Term: Dental composite resin 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental composite resin

SCOTT'S HANDHELD AUTOMIX CORE 2/pk BLUE by Scott's Dental Supply L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K022675 also covers:

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: Scott's Dental Supply L.l.c.

Sources (1)

FDA UDI 20091673-6efa-4d93-bce2-dd77e7577c08 35 fields · synced May 30, 2026