FDA.reportPublic FDA data

CoDiagnostiX

Primary DI
07630031755537
Brand
CoDiagnostiX
Company
Institut Straumann AG
Model
Anatomic drill guides
Catalog number
010.4030
Device description
Surgical Guide with cut profile, 3D printed
Published
2022-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDRIVER, WIRE, AND BONE DRILL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193301000coDiagnostiXDental Wings GmbH2021-06-21DZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031755537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031755537076300317555377630031755537

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 made of synthetic polymer materials and 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031711366NAPlan Abutments025.2602-042022-12-02
07630031711410NAPlan Abutments025.2612-042022-12-02
07630031711427NAPlan Abutments025.2613-042022-12-02
07630031711465NAPlan Abutments025.2621-042022-12-02
07630031712639NATransfer aids025.4913-042022-12-02
07630031722645NAPlan Abutments048.073V42022-12-02
07630031723000NAConventional impression048.122V42022-12-02
07630031723970NAPlan Abutments048.276V42022-12-02
07630031724021NAPlan Abutments048.283V42022-12-02
07630031724038NAPlan Abutments048.284V42022-12-02
07630031724045NAPlan Abutments048.285V42022-12-02
07630031724052NAPlan Abutments048.286V42022-12-02
07630031724069NAPlan Abutments048.287V42022-12-02
07630031734884N!CE Glass Ceramic Blocks For Amann GirrbachMilling Materials010.71352023-08-24
07630031734921N!CE Glass Ceramic Blocks For Amann GirrbachMilling Materials010.71392022-04-14
07630031731012n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70522019-06-18
07630031731029n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70532019-06-18
07630031731050n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70562019-06-18
07630031731067n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70572019-06-18
07630031731081n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70592019-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327652772TPXSTRYKER CORPORATIONDZJ2026-04-13
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00810007633350AccuPlan SystemMedcadDZJ2025-10-31
00810007633367AccuPlan SystemMedcadDZJ2025-10-31
00810007633374AccuPlan SystemMedcadDZJ2025-10-31
00810007633381AccuPlan SystemMedcadDZJ2025-10-31
00810007633336AccuPlan System MedcadDZJ2025-10-30
00840124524255FuzeFix Max FTFUSION ORTHOPEDICS, LLCDZJ2025-10-23
00840124524262FuzeFix Max FTFUSION ORTHOPEDICS, LLCDZJ2025-10-23
00810007633183AccuPlan System MedcadDZJ2024-10-18
00810007633190AccuPlan System MedcadDZJ2024-10-18
00810007633213AccuPlan System MedcadDZJ2024-10-18
00810007633220AccuPlan System MedcadDZJ2024-10-18
00810007633237AccuPlan System MedcadDZJ2024-10-18
00810007631547AccuPlan SystemMedcadDZJ2023-11-30
00810007632209AccuPlan SystemMedcadDZJ2023-11-02
00810007632223AccuPlan SystemMedcadDZJ2023-11-02
00810007631202AccuPlan System MedcadDZJ2023-11-01
00810007631257AccuPlan System MedcadDZJ2023-11-01
00810007631264AccuPlan SystemMedcadDZJ2023-11-01
00810007631561AccuPlan SystemMedcadDZJ2023-11-01
00810007631677AccuPlan System MedcadDZJ2023-11-01
00810007631813AccuPlan System MedcadDZJ2023-11-01
00810007631820AccuPlan System MedcadDZJ2023-11-01
00810007631851AccuPlan System MedcadDZJ2023-11-01
00810007631875AccuPlan System MedcadDZJ2023-11-01
00810007631905AccuPlan System MedcadDZJ2023-11-01
00810007631912AccuPlan System MedcadDZJ2023-11-01
00810007631929AccuPlan System MedcadDZJ2023-11-01
00810007631936AccuPlan System MedcadDZJ2023-11-01