Aseptico
GUDID 10817417021040
Implant / Endodontic Dental Systems
ASEPTICO, INC.
Dental power tool system handpiece, remotely-driven| Primary Device ID | 10817417021040 |
| NIH Device Record Key | 3490be49-7b4d-404d-b3f3-e55dbb46785b |
| Commercial Distribution Discontinuation | 2030-09-01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aseptico |
| Version Model Number | AEU-6000ARM-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
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 |
| 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 |
| 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 | 10817417021040 [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 |
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
[10817417021040]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-22 |
| Device Publish Date | 2022-02-14 |
On-Brand Devices [Aseptico]
| 10817417021927 | Transport III Portable electrical dental delivery system without scaler. |
| 10817417022337 | Mobile Dental Cart |
| 10817417022320 | Mobile Dental Cart |
| 10817417022306 | AEU-350 Portable Dentistry System |
| 10817417021040 | Implant / Endodontic Dental Systems |
| 10817417021033 | Implant / Endodontic Dental Systems |
| 10817417021026 | Implant / Endodontic Dental Systems |
| 10817417021019 | Implant / Endodontic Dental Systems |
| 10817417021002 | Implant / Endodontic Dental Systems |
| 10817417020739 | Dental Implant Motor System is a drive system for instruments and tools used in dentistry for im |
| 10817417020104 | Mobile Dental System |
| 10817417020746 | Dental Implant Motor System with Variable-Speed Footswitch. Drive system for instruments and too |
| 10817417021828 | CUSPID GRID & CHAIN ASSY |
| 10817417021286 | Implant, Endo and Oral Surgery System |
| 10817417021262 | Implant, Endo and Oral Surgery System |
| 10817417021255 | Implant, Endo and Oral Surgery System |
| 10817417021217 | Implant, Endo and Oral Surgery System |
| 10817417021200 | Implaint, Endo and Oral Surgery Systems |
| 10817417020968 | Implant, Endo and Oral Surgery Systems |
| 10817417020951 | Implant, Endo and Oral Surgery System |
| 10817417020944 | Implant, Endo and Oral Surgery System |
| 10817417020937 | Implant, Endo and Oral Surgery System |
| 10817417020791 | Dental Implant Motor System |
| 10817417020784 | Dental Implant Motor System |
| 10817417021620 | Custom Cart Delivery |
| 10817417021491 | Portable Hydraulic Dental Chair |
| 10817417021484 | Portable Hydraulic Dental Chair |
| 10817417021477 | Portable Hydraulic Dental Chair |
| 10817417021460 | Portable Dental Chair |
| 10817417021453 | Portable Pediatric Dental Chair |
| 10817417021446 | Portable Dental Chair |
| 10817417021422 | Portable Dental Chair |
| 10817417020999 | Electric Operative Motor |
| 10817417020982 | Implant/ Endodontic Dental System |
| 10817417020975 | Implant / Endodontic Dental Systems |
| 10817417020906 | Electronic Endodontic System |
| 10817417020890 | Implant System |
| 10817417020869 | Electronic Endodontic System |
| 10817417020852 | Electronic Endodontic System |
| 10817417020821 | Electronic Endodontic System |
| 10817417020159 | Dental Implant Motor System |
| 10817417020142 | Dental Implant Motor System |
| 10817417020128 | Dental Implant Motor System |
| 10817417020111 | Dental Implant Motor System |
| 10817417020210 | Portable Dental Lamp |
| 10817417020203 | Portable Dental Lamp |
| 10817417022313 | AEU-350S GO ULTRA PORTABLE DENTAL SYSTEM W/ SCALER |
Trademark Results [Aseptico]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ASEPTICO 90235493 not registered Live/Pending |
Aseptico, Inc 2020-10-05 |
 ASEPTICO 85714165 4490233 Live/Registered |
Aseptico, Inc. 2012-08-27 |
 ASEPTICO 76416190 2693161 Live/Registered |
Aseptico, Inc. 2002-05-31 |
 ASEPTICO 76416189 2693160 Live/Registered |
Aseptico, Inc. 2002-05-31 |
 ASEPTICO 73686963 1523146 Dead/Cancelled |
INSTA-CARE PHARMACEUTICAL SERVICES INC. 1987-09-29 |
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