FDA.report

M-PRINT Splint

Primary DI
D7091084050
Brand
M-PRINT Splint
Company
Merz Dental GmbH
Model
M-PRINT Splint clear, 1000 g
Catalog number
1084050
Device description
M-PRINT Splint clear, 1000 g
Published
2022-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MQCMouthguard, Prescription

Product Code Classifications

CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7091084050PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental occlusal splint, preformed, reusableA rigid or flexible prefabricated device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporo-mandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is typically made of standard, preformed materials that are not moulded, or intended to be moulded to a specific patient. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+494381403411claudia.bobrowski@merz-dental.de

Regulatory Flags

DUNS number
324914910
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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D7091010333artegral lifeLiving mould chart artegral life A310103332025-09-01
D7091010335artVeneer lifeLiving mould chart artVeneer life A310103352025-09-01
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