FDA.reportPublic FDA data

Surgical Guide - 3D Printed Model

Primary DI
07630031739933
Brand
Surgical Guide - 3D Printed Model
Company
Institut Straumann AG
Model
2017
Catalog number
010.4021
Device description
Surgical Guide - 3D Printed Model for assistance during oral surgery.
Published
2018-07-19
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031739933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031739933076300317399337630031739933

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800 4488168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031736451Straumann BoneceramicBoneCeramic070.1982022-04-01
07630031736468Straumann BoneceramicBoneCeramic070.1992022-04-01
07630031736475Straumann BoneceramicBoneCeramic070.2002022-04-01
07630031700155STRAUMANN GRANULESBoneCeramic070.2032015-09-24
07630031700162STRAUMANN GRANULESBoneCeramic070.2042015-09-24
07630031700179STRAUMANN GRANULESBoneCeramic070.2052015-09-24
07630031739575NAAnatomic drill guides010.40212022-11-10
07630031755537CoDiagnostiXAnatomic drill guides010.40302022-04-29
07630031764263Straumann® BLC Implants - Indication WideningSLA Roxolid BL035.8218S2023-11-04
07630031764331Straumann® BLC Implants - Indication WideningSLActive Roxolid BL035.9218S2023-11-04
07630031778086NAsurgically Invasive Instruments066.50632026-06-03
07630031778093NAsurgically Invasive Instruments066.50642026-06-03
07630031778109NAsurgically Invasive Instruments066.50652026-06-03
07630031778116NAsurgically Invasive Instruments066.50662026-06-03
07630031778123NAsurgically Invasive Instruments066.50672026-06-03
07630031778130NAsurgically Invasive Instruments066.50682026-06-03
07630031778147NAsurgically Invasive Instruments066.50692026-06-03
07630031778154NAsurgically Invasive Instruments066.50702026-06-03
07630031778161NAsurgically Invasive Instruments066.50712026-06-03
07630031778192NAsurgically Invasive Instruments066.50742026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053071N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053088N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053095N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053101N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053118N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053125N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053132N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053149N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053156N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053163N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053248N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053293N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053347N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053354N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053361N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053415N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
07640149886726TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886733TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886757TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886764TRITRI Dental Implants Int. AGNDP2026-10-06
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052401N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052418N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052425N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01