SciPharm NewCore, Core Build-Up Restorative Automix

FDA UDI

Class II (US FDA UDI)

by Scientific Pharmaceuticals, Inc.

Identity

Trade Name: SciPharm NewCore, Core Build-Up Restorative Automix FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge. Blue Shade. Non-Boxed. FDA UDI
Model / Reference: SP 57-013 N FDA UDI
Description: NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge. Blue Shade. Non-Boxed. FDA UDI

Identifiers

Catalog Number: 57-013 FDA UDI
Primary DI / UDI-DI: D801SP57013N1 FDA UDI
510(k) Number: K810479 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

Yes

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental composite resin

SciPharm NewCore, Core Build-Up Restorative Automix by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Dental composite resin.

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Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
Llis — Dentscare Ltda · Class II
Capo Universal, 6 g — Schütz Dental GmbH · Class II
OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II

Cleared under the same submission

K810479 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: Scientific Pharmaceuticals, Inc.

Sources (1)

FDA UDI c9380526-2241-4f18-96f0-a9dce18839fa 37 fields · synced Jun 1, 2026