FDA.reportPublic FDA data

DENTSPLY Tulsa Dental Specialties

Primary DI
10817417020081
Brand
DENTSPLY Tulsa Dental Specialties
Company
ASEPTICO, INC.
Model
AE-250-30-T
Catalog number
AE-250-30-T
Device description
HANDPIECE, DIRECT DRIVE, AC-POWERED (MICROMOTOR)Accessory to AEU-27T.
Published
2018-06-15
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817417020081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081741702008110817417020081

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, line-poweredA hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1Pound

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure69.7 KiloPascal101.33 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius28 Degrees Celsius
Storage Environment Atmospheric Pressure69.7 KiloPascal101.33 KiloPascal
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
425 487 3157info@aseptico.com
425 487 3157gramaley@aseptico.com

Regulatory Flags#

DUNS number
016853348
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817417020197Dentsply SironaAA-65BASE-DS2026-09-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313237511ChecQPEGDENTIS CO. ,LTDEKX2026-09-29
08800313237528ChecQPEGDENTIS CO. ,LTDEKX2026-09-29
06979865810038JAS MotorDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDEKX2026-09-24
06944843624365Ultrapro TX CordlessULTRADENT PRODUCTS, INC.EKX2026-09-19
09010522003015Osstell SmartPeg Type 116Osstell ABEKX2026-08-30
09010522003022Osstell SmartPeg Type 118Osstell ABEKX2026-08-30
09010522003039Osstell SmartPeg Type 119Osstell ABEKX2026-08-30
09010522003046Osstell SmartPeg Type 120Osstell ABEKX2026-08-30
09010522003053Osstell SmartPeg Type 121Osstell ABEKX2026-08-30
09010522003060Osstell SmartPeg Type 122Osstell ABEKX2026-08-30
09010522003077Osstell SmartPeg Type 123Osstell ABEKX2026-08-30
08800313230017ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230024ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230031ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230048ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230055ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230062ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237429ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237436ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237443ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237450ChecQPEGDENTIS CO. ,LTDEKX2026-08-26