FDA UDI
In Commercial Distribution
🇺🇸 United States
Osteotomy Former
DI: D7850350T0
·
Model: 3.5mm Osteotomy Former
·
OCO BIOMEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Osteotomy Former
- Primary DI
- D7850350T0
- Version / Model
- 3.5mm Osteotomy Former
- Catalog Number
- 0350TN
- Company Name
- OCO BIOMEDICAL INC
- Labeler DUNS
- 094146123
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-22
- Public Version
- 6
- Public Version Date
- 2024-09-12
- Public Version Status
- Update
- Public Device Record Key
- 8450df8c-2726-4ec2-9b29-e5486982dc76
Device Description
3.5mm Osteotomy Former 3.5mm Diameter For placement of the 4mm ISI/TSI/ERI Maxillary Implant
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| DZA | Drill, Dental, Intraoral | Dental | 872.4130 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45714 | Fixture/appliance dental drill bit, reusable | A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D7850350T0 | HIBCC |