FDA.reportPublic FDA data

Aseptico

Primary DI
10817417021040
Brand
Aseptico
Company
ASEPTICO, INC.
Model
AEU-6000ARM-70V
Device description
Implant / Endodontic Dental Systems
Published
2022-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKXHandpiece, Direct Drive, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103399000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103399000GENERAL DENISTRY MOTORAseptico, Inc.2011-02-28EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817417021040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081741702104010817417021040

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, remotely-drivenA hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device does not incorporate a power source (e.g., an AC-powered motor). The rotational power is transferred from the power source to the endpiece via mechanical components (e.g., chains, gears, shafts) incorporated in the handpiece or via an external flexible drive system (e.g., a Bowden cable); the endpiece(s) are not included. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius28 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
14254873157Regulatory@aseptico.com

Regulatory Flags#

DUNS number
016853348
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817417021347Treace PercuplastyAA-1070TRE-TRAY2026-04-13
10817417020227AsepticoAEU-27DTCR2026-04-08
10817417020326AsepticoAEU-27DTCR-W2026-04-08
10817417021323AsepticoAE-24DIS-102026-04-08
10817417021330AsepticoAE-24DIS2026-04-08
10817417020166Dentsply SironaAEU-65-DS2022-12-08
10817417020371AsepticoAEU-1070-WAEU-10702026-04-06
10817417020388AsepticoAEU-1070-70V-W2026-04-06
10817417020418AsepticoAEU-7000E-WAEU-7000E-W2026-04-03
10817417020425AsepticoAEU-7000E-70V-WAEU-7000E-70V-W2026-04-03
10817417020432AsepticoAEU-7000L-WAEU-7000L-W2026-04-03
10817417020449AsepticoAEU-7000L-70V-WAEU-7000L-70V-W2026-04-03
10817417020395AsepticoAEU-6000-WAEU-6000-W2025-12-16
10817417020401AsepticoAEU-6000-70V-WAEU-6000-70V-W2025-12-16
10817417020456AsepticoAEU-350-WAEU-3502025-12-16
10817417020463AsepticoAEU-350S-WAEU-350S-W2025-12-16
10817417020319Treace PercuplastyAEU-1070TRE-70V2025-08-27
10817417022313AsepticoAEU-350SAEU-350S2024-09-18
10817417020203AsepticoALU-40MOM2023-05-03
10817417020210AsepticoALU-40MOM-S2023-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858466005257ENDOMAXDENTAMERICA, INC.EKX2026-04-22
00858466005240ENDOMAXDENTAMERICA, INC.EKX2026-04-21
10817417020227AsepticoASEPTICO, INC.EKX2026-04-08
10817417020326AsepticoASEPTICO, INC.EKX2026-04-08
10817417020371AsepticoASEPTICO, INC.EKX2026-04-06
10817417020388AsepticoASEPTICO, INC.EKX2026-04-06
10817417020418AsepticoASEPTICO, INC.EKX2026-04-03
10817417020425AsepticoASEPTICO, INC.EKX2026-04-03
10817417020432AsepticoASEPTICO, INC.EKX2026-04-03
10817417020449AsepticoASEPTICO, INC.EKX2026-04-03
08809260475458E-CUBESaeshin Precision Co., Ltd.EKX2026-03-31
10194665008475A-decA-DEC, INC.EKX2026-02-19
10194665008482A-decA-DEC, INC.EKX2026-02-19
10194665008499A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.EKX2026-02-19
10194665008512A-decA-DEC, INC.EKX2026-02-19
10194665008529A-decA-DEC, INC.EKX2026-02-19
10194665008550A-decA-DEC, INC.EKX2026-02-19
09010522002513SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002537SmartPeg Type 137Osstell ABEKX2026-02-09
D100B00XSGO000000X-Smart Go Cordless endo motor with integrated apex locatorFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100B00XSGOAC0006X-Smart® Go Contra-angle (6:1)FORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100B00XSGOAC0007X-Smart® Go Protective silicone sleeveFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100BSPXSGOAC0005X-Smart® Go Power bankFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
09010522002674MEGA ISQ II InstrumentOsstell ABEKX2025-09-26
00860011518334InnerView® System Smart Tips Perimetrics, Inc.EKX2025-07-31
09010522002575Osstell SmartPeg Type 113Osstell ABEKX2025-03-27
09010522002599Osstell SmartPeg Type 114Osstell ABEKX2025-03-27
09010522002612Osstell SmartPeg Type 115Osstell ABEKX2025-03-27
09010522002483SmartPeg Type 117Osstell ABEKX2024-05-15