Aseptico AEU-6000-70V
GUDID 10817417021019
Implant / Endodontic Dental Systems
ASEPTICO, INC.
Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric| Primary Device ID | 10817417021019 |
| NIH Device Record Key | 6bedf366-89be-40bb-a1a3-ea84368cc631 |
| Commercial Distribution Discontinuation | 2030-09-01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aseptico |
| Version Model Number | AEU-6000-70V |
| Catalog Number | AEU-6000-70V |
| 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 | 10817417021019 [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 |
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
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[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
Moist Heat or Steam Sterilization
[10817417021019]
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 |
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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