FDA UDI
In Commercial Distribution
🇺🇸 United States
Candid Impression Kit
DI: 00850004223000
·
Model: IKDIGITAL00005
·
CANDID CARE CO.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Candid Impression Kit
- Primary DI
- 00850004223000
- Version / Model
- IKDIGITAL00005
- Company Name
- CANDID CARE CO.
- Labeler DUNS
- 108729170
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-03
- Public Version
- 2
- Public Version Date
- 2020-05-20
- Public Version Status
- Update
- Public Device Record Key
- 71dc1288-eb66-4a77-8595-9e927d1c912c
Device Description
Candid finished impression kit (Old Tray + Kett Putty + Digital+toothbrush)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIG | Retractor, All Types | Dental | 872.4565 | 1 |
| EHY | Tray, Impression, Preformed | Dental | 872.6880 | 1 |
| ELW | Material, Impression | Dental | 872.3660 | 2 |
| EFW | Toothbrush, Manual | Dental | 872.6855 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850004223000 | GS1 |
Customer Contacts
- Phone
- 917-754-2056
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082560 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 77 Degrees Fahrenheit