DEVICE: DentalMonitoring - Straumann (03760405340251)

Device Identifier (DI) Information

DentalMonitoring - Straumann
003
In Commercial Distribution
2001-001
DENTAL MONITORING
03760405340251
GS1

1
269129881 *Terms of Use
Dental treatment remote monitoring
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
SBC Dental Image Analyzer
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
DEN230035 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

12ae3763-4b93-4a87-91be-a568488444c2
June 16, 2025
1
June 06, 2025
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
1 737 300 6011
support+dmus1@dentalmonitoring.com
CLOSE