FDA UDI
In Commercial Distribution
🇺🇸 United States
NATURE-CRYL®
DI: D6583498231
·
Model: 349823
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NATURE-CRYL®
- Primary DI
- D6583498231
- Version / Model
- 349823
- Catalog Number
- 349823
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c3c0e7a2-8cfa-4c4b-82de-d97939a40764
Device Description
NATURE-CRYL® SUPER HI IMPACT 32oz LIQUID
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 |
|---|---|---|---|---|
| 16729 | Denture base resin, heat-cured | A resin that requires heat for polymerization intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually consists of an acrylic monomer of methyl methacrylate (typically supplied as a powder) that becomes a polymer (polymethylmethacrylate or PMMA) when mixed with a catalyst such as benzoylperoxide (typically supplied as a liquid). Reinforcing fillers may be included in the resin to increase its strength and/or durability. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D6583498231 | HIBCC |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051358 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 32 | Fluid Ounce |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 27 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 60 – 80 Degrees Fahrenheit