FDA UDI
In Commercial Distribution
🇺🇸 United States
MECTRON
DI: E322035100201010
·
Model: P2-3 -US
·
MECTRON SPA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MECTRON
- Primary DI
- E322035100201010
- Version / Model
- P2-3 -US
- Catalog Number
- 03510020-101
- Company Name
- MECTRON SPA
- Labeler DUNS
- 436664734
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 499fc737-5326-485d-bd5a-37a10211cf90
Device Description
P2-3 -US is a implant site preparation dental insert to be used in conjunction with Mectron Piezosurgery handpieces.
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
- No
- 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 |
|---|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 872.4850 | 2 |
| 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 | E322035100201010 | HIBCC |
Customer Contacts
- Phone
- +1 6144594922
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151248 | 000 |