FDA UDI
In Commercial Distribution
🇺🇸 United States
CHECK-BITE™
DI: D6582620251
·
Model: 262025
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- CHECK-BITE™
- Primary DI
- D6582620251
- Version / Model
- 262025
- Catalog Number
- 262025
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 4
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- 245a4187-1306-4af1-86e9-6b23f54682a6
Device Description
CHECK-BITE™ Occlusal Inserts, Package of 25
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
- No
- 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 |
|---|---|---|---|---|
| ELW | MATERIAL, IMPRESSION | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44575 | Dental impression spacer | A device comprised of thin layers of wax or other plastic materials intended to be applied to the surface of edentulous ridges and dental structures before the preliminary application of impression material. After producing the preliminary model, the device is discarded, thus providing an equidistant space between the oral structures and the impression tray that allows escape of excess impression material and entrapped air, and facilitates manipulation during final impression taking. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D6582620251 | HIBCC | ||||
| Unit of Use | D6582620250 | HIBCC |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K851469 | 000 |