FDA UDI
In Commercial Distribution
🇺🇸 United States
American Dental Implant
DI: D896FSD241150
·
Model: FSD24115
·
AMERICAN DENTAL IMPLANT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- American Dental Implant
- Primary DI
- D896FSD241150
- Version / Model
- FSD24115
- Catalog Number
- FSD24115
- Company Name
- AMERICAN DENTAL IMPLANT CORPORATION
- Labeler DUNS
- 835556429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-31
- Public Version
- 3
- Public Version Date
- 2020-01-09
- Public Version Status
- Update
- Public Device Record Key
- 6e580eed-1e0c-4656-8a8d-4d59dc03646e
Device Description
2.4mm "Skinny" Diameter Drill 11.5mm Length
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
- 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 |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
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 | D896FSD241150 | HIBCC |
Customer Contacts
- Phone
- 800-511-0661
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K945706 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage: Store In An Approved Sterilization Pouch