FDA UDI
In Commercial Distribution
🇺🇸 United States
Healing Abutment
DI: D890HACNP4560
·
Model: HACNP456
·
SPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Healing Abutment
- Primary DI
- D890HACNP4560
- Version / Model
- HACNP456
- Company Name
- SPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.
- Labeler DUNS
- 086863437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-06
- Public Version
- 1
- Public Version Date
- 2019-09-16
- Public Version Status
- New
- Public Device Record Key
- 0010f53e-ff9c-49f7-abbd-7ed193bd6a75
Device Description
Healing Abutment Conicap NP 4.5mm H 6mm
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46122 | Dental implant suprastructure, temporary, preformed, reusable | A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D890HACNP4560 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170372 | 000 |