DEVICE: DentalMonitoring - Straumann (03760405340251)
Device Identifier (DI) Information
DentalMonitoring - Straumann
003
In Commercial Distribution
2001-001
DENTAL MONITORING
003
In Commercial Distribution
2001-001
DENTAL MONITORING
Dental treatment remote monitoring
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 63979 | Patient self-taken medical image communication software |
An application software program intended to facilitate diagnosis/monitoring of a patient at home (e.g., between healthcare facility visits) by allowing self-taken patient images (i.e., taken by the patient in the home) to be sent to a clinician for review.
|
Active | false |
| 61087 | Clinical management support software |
An application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| SBC | Dental Image Analyzer |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| DEN230035 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
12ae3763-4b93-4a87-91be-a568488444c2
June 16, 2025
1
June 06, 2025
June 16, 2025
1
June 06, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1 737 300 6011
support+dmus1@dentalmonitoring.com
support+dmus1@dentalmonitoring.com