FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NATURE-CRYL®
DI: D6583497021
·
Model: 349702
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NATURE-CRYL®
- Primary DI
- D6583497021
- Version / Model
- 349702
- Catalog Number
- 349702
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 5
- Public Version Date
- 2018-08-09
- Public Version Status
- Update
- Public Device Record Key
- d335c8ec-5195-4d9b-9057-a676c6d6becd
- Distribution End Date
- 2018-05-01
Device Description
NATURE-CRYL® HI-20ET COE-LOR MODERATE 1Ib POWDER
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
- 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 |
|---|---|---|---|---|
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17609 | Denture reliner, hard | A denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which sets to a hard state. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D6583497021 | HIBCC |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K792427 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1 | Pound |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 27 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 60 – 80 Degrees Fahrenheit