FDA UDI
In Commercial Distribution
🇺🇸 United States
Osteon Medical
DI: D102SGKBF20
·
Model: 1
·
IMPLANT SOLUTIONS PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Osteon Medical
- Primary DI
- D102SGKBF20
- Version / Model
- 1
- Company Name
- IMPLANT SOLUTIONS PTY LTD
- Labeler DUNS
- 756242111
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-05
- Public Version
- 2
- Public Version Date
- 2025-02-06
- Public Version Status
- Update
- Public Device Record Key
- bff52b02-cb05-4afa-bd84-2f62f7f83db6
Device Description
Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61641 | Dental implant abutment analog, intraoral-scanning, single-use | An intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D102SGKBF20 | HIBCC |
Customer Contacts
- Phone
- +61392640111
- [email protected]