Primeprint Splint SF 1000g

FDA UDIEUDAMED

Class I (US FDA UDI)

by DETAX GmbH

Identity

Trade Name: Primeprint Splint SF 1000g FDA UDI
Generic Name: Removable dental occlusal splint, custom-made FDA UDI
Model / Reference: 04416 FDA UDI

Identifiers

Primary DI / UDI-DI: EDET044161 FDA UDI
FDA Product Code: DYJ FDA UDI
KMY FDA UDI
MQC FDA UDI
GMDN Term: Removable dental occlusal splint, custom-made FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.5410 FDA UDI
872.5525 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

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

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Removable dental occlusal splint, custom-made

Primeprint Splint SF 1000g by DETAX GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Removable dental occlusal splint, custom-made.

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BENCO — BENCO DENTAL SUPPLY CO. · Class I
Vertex-Dental BV — Vertex-Dental B.V. · Class I
M-PM Crystal — Merz Dental GmbH · U
M-PM Crystal — Merz Dental GmbH · U
IMPRIMO LC Splint comfort — Pro3Dure Medical · Class I
BENCO — BENCO DENTAL SUPPLY CO. · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: DETAX GmbH

Sources (2)

FDA UDI c726dd08-1515-44e2-8664-9e5bde3bd629 32 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 18, 2026