FDA.reportPublic FDA data

M-PRINT Surgical guide HT

Primary DI
D7091084041
Brand
M-PRINT Surgical guide HT
Company
Merz Dental GmbH
Model
M-PRINT Surgical guide HT spring-green, 1000 g
Catalog number
1084041
Device description
M-PRINT Surgical guide HT spring-green, 1000 g
Published
2023-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBHMaterial, Impression Tray, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7091084041PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental guided surgery reference plateA non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for implant placement/fixation). It is a plastic plate of a predefined shape and hole configuration for placement of dental guided surgery reference pins to form a link between a chairside cone beam computerized tomography (CBCT) scan and a coordinate system for dental laboratory fabrication of the scan template (used to scan the patient) and then the surgical dental implant template. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+494381403411claudia.bobrowski@merz-dental.de

Regulatory Flags#

DUNS number
324914910
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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D7091019188M-PM DiscM-PM Disc, PMMA-Disc, shade A3.5 translucent ZIR t10191882016-09-24
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D7091019239M-PM DiscM-PM Disc, PMMA-Disc, shade B2 translucent thickne10192392020-04-07
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D7091019429M-PM DiscM-PM Disc, PMMA-Disc, shade C1 translucent thickne10194292019-12-05

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