FDA UDI
In Commercial Distribution
🇺🇸 United States
American Dental Implant
DI: D896ST0
·
Model: ST
·
AMERICAN DENTAL IMPLANT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- American Dental Implant
- Primary DI
- D896ST0
- Version / Model
- ST
- Catalog Number
- ST
- 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
- 2019-08-09
- Public Version Status
- Update
- Public Device Record Key
- b9d52470-5e36-4f81-bd3d-ade9bae669af
Device Description
Surgical Template for Radiographs
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 47974 | Dental implant x-ray template | A non-sterile device intended to be used by a dentist or a surgeon to radiographically determine the appropriate size of a dental implant to be inserted into the jawbone of a patient prior to dental surgery. It is typically made of a translucent plastic sheet marked with incremented graduations that correspond to the lengths of the implants available. The device is typically available in a set with graduated markings and an individual sheet is placed over the x-ray of the jawbone so that the final selection of implant size can be determined against the depth of bone shown by the x-ray. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D896ST0 | HIBCC |
Customer Contacts
- Phone
- 8005110661
- [email protected]