FDA.report

DD Bio Splint P HI

Primary DI
EDDIK401301
Brand
DD Bio Splint P HI
Company
Dental Direkt GmbH
Model
98H30
Catalog number
K40130
Device description
DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems. DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months.
Published
2022-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MQCMouthguard, Prescription

Product Code Classifications

CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EDDIK401301PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Device Sizes

TypeValueUnit
Height30Millimeter
Outer Diameter98.5Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+495225863190info@dentaldirekt.de

Regulatory Flags

DUNS number
313214171
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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EDDI35753039141Nacera® Pearl Natural98H18 D235753039142025-10-10
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