Spee-Dee™ Build-Up

FDA UDI

Class II (US FDA UDI)

by Pulpdent Corporation

Identity

Trade Name: SPEE-DEE™ BUILD-UP FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: 50 mL automix cartridge + 30 mix tips -Multi-purpose core and tooth build up resin- dual cure, fluoride releasing FDA UDI
Model / Reference: SBU50 FDA UDI
Description: 50 mL automix cartridge + 30 mix tips -Multi-purpose core and tooth build up resin- dual cure, fluoride releasing FDA UDI

Identifiers

Primary DI / UDI-DI: D701SBU502 FDA UDI
FDA Product Code: EMA FDA UDI
EBF FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3275 FDA UDI
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

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

Dimensions & Sizes

Size: Total Volume — 50 Milliliter FDA UDI

Category: Dental composite resin

Spee-Dee™ Build-Up by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental composite resin.

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Forma S — ULTRADENT PRODUCTS, INC. · Class II
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SimpliShade — KERR CORPORATION · Class II
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

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: Pulpdent Corporation

Sources (1)

FDA UDI 78187c97-1534-47e2-9864-a55c5099b903 34 fields · synced Jun 9, 2026