FDA UDI
In Commercial Distribution
🇺🇸 United States
Dimension™ Garant™ L
DI: J001702011127890
·
Model: 36515
·
3M Deutschland GmbH
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
4
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Basic Information
- Brand Name
- Dimension™ Garant™ L
- Primary DI
- J001702011127890
- Version / Model
- 36515
- Catalog Number
- 36515
- Company Name
- 3M Deutschland GmbH
- Labeler DUNS
- 315731711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 188435a0-728d-47c1-913a-5fd3829e0e82
Device Description
3M™ ESPE™ Dimension™ Garant™ L VPS Impression Material Refill, 36515
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELW | MATERIAL, IMPRESSION | Dental | 872.3660 | 2 |
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
| 58399 | Dental material mixing nozzle | A device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J001702011127890 | HIBCC | ||||
| Unit of Use | J001702011127894 | HIBCC |
Customer Contacts
- Phone
- +1(800)634-2249
- [email protected]