FDA UDI
In Commercial Distribution
🇺🇸 United States
ZERAMEX® RB Abutment Angular 15, 1mm (incl. Screw)
DI: 07640161391963
·
Model: RB16515
·
Dentalpoint AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZERAMEX® RB Abutment Angular 15, 1mm (incl. Screw)
- Primary DI
- 07640161391963
- Version / Model
- RB16515
- Catalog Number
- RB16515
- Company Name
- Dentalpoint AG
- Labeler DUNS
- 483229493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-30
- Public Version
- 1
- Public Version Date
- 2018-12-31
- Public Version Status
- New
- Public Device Record Key
- 842953b8-69bf-48c9-80cc-2c126a34c39b
Device Description
Prosthetics
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
- Yes
- PM Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55847 | Dental implant system | A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640161391963 | GS1 |
Customer Contacts
- Phone
- +41443883630
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180184 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry, Keep out of sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius