SYMPRESS 60001000
GUDID J009600010000
Dental impression material mixer, type 1
Renfert GmbH
Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer Dental impression material mixer| Primary Device ID | J009600010000 |
| NIH Device Record Key | 7a6ce431-3203-44ae-96ea-7cdf7a138fce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SYMPRESS |
| Version Model Number | 60001000 |
| Catalog Number | 60001000 |
| Company DUNS | 328502976 |
| Company Name | Renfert GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J009600010000 [Primary] |
FDA Product Code
| EFD | Amalgamator, Dental, Ac-Powered |
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 | 2023-07-18 |
| Device Publish Date | 2023-07-10 |
Devices Manufactured by Renfert GmbH
| J00925620010000 - Dynamix Speed 2 | 2023-07-18 Dental impression material mixer, Brand Kulzer GmbH |
| J00927610010000 - DUOMIX II | 2023-07-18 Dental impression material mixer, Brand Dentsply-Sirona |
| J00927700010000 - PROMIX one | 2023-07-18 Dental mixer of Surefill one and Calibra Bio capsules, Brand Dentsply Sirona |
| J009600010000 - SYMPRESS | 2023-07-18Dental impression material mixer, type 1 |
| J009600010000 - SYMPRESS | 2023-07-18 Dental impression material mixer, type 1 |
| J009610010000 - SYMPRESS II | 2023-07-18 Dental impression material mixer, type 2 |
| J009660000000 - temp:ex | 2023-07-18 Cleanser for dissolving temporary cement from dental restorations, liquid |
| J009670000000 - help:ex plaque p | 2023-07-18 Cleanser for the removal of tartar and plaque on dental prostheses, Portioned with neutraliser, powder |
| J009670000010 - help:ex plaque p, sample | 2023-07-18 Cleanser for the removal of tartar and plaque on dental prostheses, Portioned with neutraliser, powder, sample |
Trademark Results [SYMPRESS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYMPRESS 79053125 not registered Dead/Abandoned |
Heineken Supply Chain B.V. 2008-03-20 |
 SYMPRESS 79050097 3477036 Live/Registered |
Renfert GmbH 2007-12-20 |
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