FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DENTAL ATTACHMENTS
DI: D821040CRM0
·
Model: CLEAR CAPS MICRO size 6 pc.
·
RHEIN 83 SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DENTAL ATTACHMENTS
- Primary DI
- D821040CRM0
- Version / Model
- CLEAR CAPS MICRO size 6 pc.
- Catalog Number
- 040CRM
- Company Name
- RHEIN 83 SRL
- Labeler DUNS
- 439240722
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-22
- Public Version
- 2
- Public Version Date
- 2021-01-21
- Public Version Status
- Update
- Public Device Record Key
- a7812f11-edd2-4dd7-ac6c-c86ccf3914ed
- Distribution End Date
- 2021-01-20
Device Description
DISPOSABLE device in plastic material to be embodied in a removable prosthesis.To provide retention with the anchorage provided by the corresponding metal attachment fixed in the mouth.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGG | Attachment, Precision, All | Dental | 872.3165 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64322 | Dental precision attachment fitting/adjustment tool | A manual dental laboratory instrument intended to be used in a dental laboratory during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments. It is in the form of a handle with a distal end designed to perform a dedicated function (e.g., facilitate the parallel placement of a male attachment, remove/exchange/adjust an attachment, insert a retention insert, tighten a screwable element of an attachment); some types may be heated to enable melting, or attached to a motorized handpiece (e.g., drill). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D821040CRM0 | HIBCC |