FDA UDI
In Commercial Distribution
🇺🇸 United States
Coredent Surgical Guide
DI: D97121455360
·
Model: 1
·
Coredent
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Coredent Surgical Guide
- Primary DI
- D97121455360
- Version / Model
- 1
- Company Name
- Coredent
- Labeler DUNS
- 004030496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-23
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- f073b232-4d41-4dd2-8a0c-3fb7a7ec6535
Device Description
Surgical Guide
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
- 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
- Yes
- Sterilization Methods
- Liquid Chemical
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 |
|---|---|---|---|---|
| 63484 | Dental implantation drilling template, custom-made | A custom-made device intended to be used by a dental surgeon to guide drilling in the jawbone of a patient during the first stage of a guided dental implantation procedure for dental implant or orthodontic mini-implant placement/fixation. It is in the form of a shaped plate with a predefined hole(s) or a thermoformed mouldable cylinder and is capable of being used on fully and partially edentulous patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D97121455360 | HIBCC |