NATURE-CRYL® 349819
GUDID 10386040008082
NATURE-CRYL® SUPER HI IMPACT HEAVY 5lb POWDER
Gc America Inc.
Dental acrylic resin| Primary Device ID | 10386040008082 |
| NIH Device Record Key | 56c5225f-7678-4aa6-87a5-329e26a9db42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NATURE-CRYL® |
| Version Model Number | 349819 |
| Catalog Number | 349819 |
| Company DUNS | 005473608 |
| Company Name | Gc America Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com |
Device Dimensions
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
Operating and Storage Conditions
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10386040008082 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051358
FDA Product Code
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-19 |
| Device Publish Date | 2022-07-11 |
On-Brand Devices [NATURE-CRYL®]
| D6583497031 | NATURE-CRYL ® HI-20ET COE-LOR HEAVY 1Ib POWDER |
| D6583496571 | NATURE-CRYL® MC CLEAR 1Ib POWDER |
| D6583496561 | NATURE-CRYL® MC ORIGINAL 1Ib POWDER |
| D6583496551 | NATURE-CRYL® MC LIGHT REDDISH PINK 1Ib POWDER |
| D6583496541 | NATURE-CRYL® MC LIGHT 1Ib POWDER |
| D6583496531 | NATURE-CRYL® MC COE-LOR HEAVY 1Ib POWDER |
| D6583496521 | NATURE-CRYL® MC COE-LOR MODERATE 1Ib POWDER |
| D6583496511 | NATURE-CRYL® MC COE-LOR MILD 1lb POWDER |
| D6583496501 | NATURE-CRYL® MC LIGHT FIBERED + 1lb POWDER |
| 10386040008280 | NATURE-CRYL® POUR CLEAR 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008273 | NATURE-CRYL® POUR ORIGINAL 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008266 | NATURE-CRYL® POUR LIGHT REDDISH PINK 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008259 | NATURE-CRYL® POUR LIGHT 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008242 | NATURE-CRYL® POUR COE-LOR HEAVY 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008235 | NATURE-CRYL® POUR COE-LOR MODERATE 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008228 | NATURE-CRYL® POUR COE-LOR MILD 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008211 | NATURE-CRYL® POUR COE LIGHT FIBERED + 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008204 | NATURE-CRYL® POUR 300mL LIQUID |
| 10386040008198 | NATURE-CRYL® SUPER HI IMPACT HEAVY 25lb POWDER |
| 10386040008181 | NATURE-CRYL® SUPER HI IMPACT MODERATE 25lb POWDER |
| 10386040008174 | NATURE-CRYL® SUPER HI IMPACT MILD 25lb POWDER |
| 10386040008167 | NATURE-CRYL® SUPER HI IMPACT LIGHT REDDISH PINK 25lb POWDER |
| 10386040008150 | NATURE-CRYL® SUPER HI IMPACT LIGHT 25lb POWDER |
| 10386040008143 | NATURE-CRYL® SUPER HI IMPACT ORIGINAL 25lb POWDER |
| 10386040008136 | NATURE-CRYL® SUPER HI IMPACT LIGHT FIBERED+ 25lb POWDER |
| 10386040008129 | NATURE-CRYL® SUPER HI IMPACT 32oz LIQUID |
| 10386040008112 | NATURE-CRYL® SUPER HI IMPACT ORIGINAL 5lb POWDER |
| 10386040008105 | NATURE-CRYL® SUPER HI IMPACT LIGHT REDDISH PINK 5lb POWDER |
| 10386040008099 | NATURE-CRYL® SUPER HI IMPACT LIGHT 5lb POWDER |
| 10386040008082 | NATURE-CRYL® SUPER HI IMPACT HEAVY 5lb POWDER |
| 10386040008075 | NATURE-CRYL® SUPER HI IMPACT MODERATE 5lb POWDER |
| 10386040008068 | NATURE-CRYL® SUPER HI IMPACT MILD 5lb POWDER |
| 10386040008051 | NATURE-CRYL® SUPER HI IMPACT LIGHT FIBERED + 5lb POWDER |
| 10386040008044 | NATURE-CRYL® SUPER HI IMPACT ORIGINAL 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040008037 | NATURE-CRYL® SUPER HI IMPACT LIGHT REDDISH PINK 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040008020 | NATURE-CRYL® SUPER HI IMPACT LIGHT 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040008013 | NATURE-CRYL® SUPER HI IMPACT HEAVY 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040008006 | NATURE-CRYL® SUPER HI IMPACT MODERATE 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040007993 | NATURE-CRYL® SUPER HI IMPACT MILD 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040007986 | NATURE-CRYL® SUPER HI IMPACT LIGHT FIBERED + 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040007979 | NATURE-CRYL® SUPER HI IMPACT 8oz LIQUID |
| 10386040007870 | NATURE-CRYL® POUR LIGHT 25lb POWDER |
| 10386040007863 | NATURE-CRYL® POUR COE-LOR HEAVY 25lb POWDER |
| 10386040007856 | NATURE-CRYL® POUR LIGHT REDDISH PINK 25lb POWDER |
| 10386040007849 | NATURE-CRYL® POUR COE-LOR MODERATE 25lb POWDER |
| 10386040007832 | NATURE-CRYL® POUR COE-LOR MILD 25lb POWDER |
| 10386040007825 | NATURE-CRYL® POUR ORIGINAL 25lb POWDER |
| 10386040007818 | NATURE-CRYL® POUR COE LIGHT FIBERED + 25lb POWDER |
| 10386040007801 | NATURE-CRYL® POUR 32oz LIQUID |
| 10386040007795 | NATURE-CRYL® POUR ORIGINAL 5lb POWDER |
Trademark Results [NATURE-CRYL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NATURE-CRYL 78564641 3105228 Live/Registered |
GC America Inc. 2005-02-10 |
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