PALTOP
GUDID 10817417020807
Dental Implant Motor System
ASEPTICO, INC.
Dental surgical power tool motor, electric| Primary Device ID | 10817417020807 |
| NIH Device Record Key | 45c84a38-9193-4b98-b38d-ae73b42f24ea |
| Commercial Distribution Discontinuation | 2032-11-02 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PALTOP |
| Version Model Number | AEU-1070PTP-70V |
| Company DUNS | 016853348 |
| Company Name | ASEPTICO, 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | 425-487-3157 |
| Regulatory@aseptico.com | |
| Phone | 425-487-3157 |
| Regulatory@aseptico.com | |
| Phone | 425-487-3157 |
| Regulatory@aseptico.com | |
| Phone | 425-487-3157 |
| Regulatory@aseptico.com | |
| Phone | 425-487-3157 |
| Regulatory@aseptico.com | |
| Phone | 425-487-3157 |
| Regulatory@aseptico.com | |
| Phone | 425-487-3157 |
| Regulatory@aseptico.com | |
| Phone | 425-487-3157 |
| Regulatory@aseptico.com | |
| Phone | 425-487-3157 |
| Regulatory@aseptico.com | |
| Phone | 425-487-3157 |
| Regulatory@aseptico.com | |
| Phone | 425-487-3157 |
| Regulatory@aseptico.com | |
| Phone | 425-487-3157 |
| Regulatory@aseptico.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10817417020807 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103399
FDA Product Code
| EKX | Handpiece, Direct Drive, Ac-Powered |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10817417020807]
Moist Heat or Steam Sterilization
[10817417020807]
Moist Heat or Steam Sterilization
[10817417020807]
Moist Heat or Steam Sterilization
[10817417020807]
Moist Heat or Steam Sterilization
[10817417020807]
Moist Heat or Steam Sterilization
[10817417020807]
Moist Heat or Steam Sterilization
[10817417020807]
Moist Heat or Steam Sterilization
[10817417020807]
Moist Heat or Steam Sterilization
[10817417020807]
Moist Heat or Steam Sterilization
[10817417020807]
Moist Heat or Steam Sterilization
[10817417020807]
Moist Heat or Steam Sterilization
[10817417020807]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-14 |
| Device Publish Date | 2022-12-06 |
Devices Manufactured by ASEPTICO, INC.
| 10817417022313 - Aseptico | 2024-09-26 AEU-350S GO ULTRA PORTABLE DENTAL SYSTEM W/ SCALER |
| 10817417020203 - Aseptico | 2023-05-11 Portable Dental Lamp |
| 10817417020210 - Aseptico | 2023-05-11 Portable Dental Lamp |
| 10817417020111 - Aseptico | 2023-03-27 Dental Implant Motor System |
| 10817417020128 - Aseptico | 2023-03-27 Dental Implant Motor System |
| 10817417020142 - Aseptico | 2023-03-27 Dental Implant Motor System |
| 10817417020159 - Aseptico | 2023-03-27 Dental Implant Motor System |
| 10817417020821 - Aseptico | 2022-12-15 Electronic Endodontic System |
Trademark Results [PALTOP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PALTOP 87570958 5423163 Live/Registered |
Paltop Advanced Dental Solutions Ltd. 2017-08-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.