CoForm

FDA UDI

Class I (US FDA UDI)

by Directa AB

Identity

Trade Name: CoForm FDA UDI
Generic Name: Dental mould FDA UDI
Model / Reference: 23 Distal FDA UDI

Identifiers

Catalog Number: 604047 FDA UDI
Primary DI / UDI-DI: 17310236040474 FDA UDI
FDA Product Code: ELZ FDA UDI
GMDN Term: Dental mould FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3330 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental mould

CoForm is a dental mould device designed to provide accurate and reliable impressions for dentists. With its hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape, CoForm offers a convenient and efficient solution for creating precise dental models. By combining the benefits of direct marking and no need for nuclear registration, CoForm has become a popular choice among dental professionals. Its seamless integration with existing workflows ensures minimal disruption and streamlined operations. The device is available in various configurations to cater to diverse needs, making it an ideal option for both small and large-scale practices. With its cutting-edge technology and user-friendly interface, CoForm empowers dentists to deliver exceptional patient care while improving treatment outcomes. Whether you're a seasoned pro or just starting your practice, CoForm is the perfect tool to enhance your workflow and take your dental work to the next level.

Similar devices

Also classified as Dental mould.

TRANSPARENT CROWNS — TDV DENTAL LTDA · Class I
TRANSPARENT CROWNS — TDV DENTAL LTDA · Class I
EDS Core Forms — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
TRANSPARENT CROWNS — TDV DENTAL LTDA · Class I
TRANSPARENT CROWNS — TDV DENTAL LTDA · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
TRANSPARENT CROWNS — TDV DENTAL LTDA · Class I
TRANSPARENT CROWNS — TDV DENTAL LTDA · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Directa AB

Sources (1)

FDA UDI 1888e85b-396c-4dee-89ca-c6b09146b062 33 fields · synced Jul 25, 2026