FDA.reportPublic FDA data

M-PRINT Surgical Guide

Primary DI
D7091084040
Brand
M-PRINT Surgical Guide
Company
Merz Dental GmbH
Model
M-PRINT Surgical guide ice-blue, 1000 g
Catalog number
1084040
Device description
M-PRINT Surgical guide ice-blue, 1000 g
Published
2022-02-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
D7091084040PrimaryHIBCC0

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.

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7091019183M-PM DiscM-PM Disc, PMMA-Disc, shade BL4 translucent ZIR th10191832016-09-24
D7091019186M-PM DiscM-PM Disc, PMMA-Disc, shade A2 translucent ZIR thi10191862016-09-24
D7091019187M-PM DiscM-PM Disc, PMMA-Disc, shade A3 translucent ZIR thi10191872016-09-24
D7091019188M-PM DiscM-PM Disc, PMMA-Disc, shade A3.5 translucent ZIR t10191882016-09-24
D7091019189M-PM DiscM-PM Disc, PMMA-Disc, shade A4 translucent ZIR thi10191892016-09-24
D7091019236M-PM DiscM-PM Disc, PMMA-Disc, shade A2 translucent thickne10192362020-04-07
D7091019237M-PM DiscM-PM Disc, PMMA-Disc, shade A3 translucent thickne10192372020-04-07
D7091019238M-PM DiscM-PM Disc, PMMA-Disc, shade B1 translucent thickne10192382020-04-07
D7091019239M-PM DiscM-PM Disc, PMMA-Disc, shade B2 translucent thickne10192392020-04-07
D7091019240M-PM DiscM-PM Disc, PMMA-Disc, shade A1 translucent thickne10192402020-04-07
D7091019420M-PM DiscM-PM Disc, PMMA-Disc, shade A1 translucent thickne10194202019-12-05
D7091019421M-PM DiscM-PM Disc, PMMA-Disc, shade A2 translucent thickne10194212019-12-05
D7091019422M-PM DiscM-PM Disc, PMMA-Disc, shade A3 translucent thickne10194222019-12-05
D7091019423M-PM DiscM-PM Disc, PMMA-Disc, shade A3,5 translucent thick10194232019-12-05
D7091019424M-PM DiscM-PM Disc, PMMA-Disc, shade A4 translucent thickne10194242019-12-05
D7091019425M-PM DiscM-PM Disc, PMMA-Disc, shade B1 translucent thickne10194252019-12-05
D7091019426M-PM DiscM-PM Disc, PMMA-Disc, shade B2 translucent thickne10194262019-12-05
D7091019427M-PM DiscM-PM Disc, PMMA-Disc, shade B3 translucent thickne10194272019-12-05
D7091019428M-PM DiscM-PM Disc, PMMA-Disc, shade B4 translucent thickne10194282019-12-05
D7091019429M-PM DiscM-PM Disc, PMMA-Disc, shade C1 translucent thickne10194292019-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456206942JMUJMU DENTAL, INCEBH2026-07-09
00840456207024JMUJMU DENTAL, INCEBH2026-07-09
00840456207031JMUJMU DENTAL, INCEBH2026-07-09
00840456207048JMUJMU DENTAL, INCEBH2026-07-09
00840456207055JMUJMU DENTAL, INCEBH2026-07-09
00840456207062JMUJMU DENTAL, INCEBH2026-07-09
00840456207079JMUJMU DENTAL, INCEBH2026-07-09
00840456207086JMUJMU DENTAL, INCEBH2026-07-09
00840456207093JMUJMU DENTAL, INCEBH2026-07-09
00840456207109JMUJMU DENTAL, INCEBH2026-07-09
00840456209332JMUJMU DENTAL, INCEBH2026-07-09
00840456209349JMUJMU DENTAL, INCEBH2026-07-09
00840456209356JMUJMU DENTAL, INCEBH2026-07-09
00840456214138JMUJMU DENTAL, INCEBH2026-07-09
00840456214145JMUJMU DENTAL, INCEBH2026-07-09
00840456214152JMUJMU DENTAL, INCEBH2026-07-09
00840456214169JMUJMU DENTAL, INCEBH2026-07-09
00840456214176JMUJMU DENTAL, INCEBH2026-07-09
00840456214183JMUJMU DENTAL, INCEBH2026-07-09
00840456214190JMUJMU DENTAL, INCEBH2026-07-09
00840456214206JMUJMU DENTAL, INCEBH2026-07-09
00840456214213JMUJMU DENTAL, INCEBH2026-07-09
00840456214220JMUJMU DENTAL, INCEBH2026-07-09
00840456223680JMUJMU DENTAL, INCEBH2026-07-09
00840456223697JMUJMU DENTAL, INCEBH2026-07-09
00840456223703JMUJMU DENTAL, INCEBH2026-07-09
00840456223710JMUJMU DENTAL, INCEBH2026-07-09
00840456223727JMUJMU DENTAL, INCEBH2026-07-09
00840456223734JMUJMU DENTAL, INCEBH2026-07-09
00840456223741JMUJMU DENTAL, INCEBH2026-07-09