FDA UDI
In Commercial Distribution
🇺🇸 United States
ACTEON
DI: 03609820875361
·
Model: SL INTRALIFT KIT PZT2
·
SATELEC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACTEON
- Primary DI
- 03609820875361
- Version / Model
- SL INTRALIFT KIT PZT2
- Catalog Number
- F87536
- Company Name
- SATELEC
- Labeler DUNS
- 381582196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b90fa2ab-11e3-4c85-aa17-1ead1c2a482e
Device Description
The hydrodynamic sinus lift technique by the crestal approach. The diamond-coated tips, of increasing diameters (from 1.35mm to 2.80mm), are designed to drill and widen gradually the access canal to the Schneider membrane. The sterile spray cools down the tips to avoid any rise in temperature, which could lead to tissue damage. The membrane elevation is achieved using the TKW5 by means of microcavitation.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DZI | Drill, Bone, Powered | Dental | 872.4120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47015 | Dental ultrasonic surgical system handpiece tip | A removable endpiece intended to be attached to a dental ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment and cut bone during dental surgery. The device is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). It is used for implant site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty, and osteotomy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03609820875361 | GS1 |
Customer Contacts
- Phone
- +33556340607
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091252 | 000 |