FDA.reportPublic FDA data

Aseptico

Primary DI
10817417020036
Brand
Aseptico
Company
ASEPTICO, INC.
Model
AEU-525CFH
Catalog number
AEU-525CFH
Device description
Transport III Portable electrical dental delivery system with built in Piezo ultrasonic scaler, handpieces, and military spec case
Published
2017-04-04
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
EIAUnit, Operative Dental
EKXHandpiece, Direct Drive, Ac-Powered
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1
EKXHandpiece, Direct Drive, Ac-PoweredDental1
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130693000AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEMAseptico, Inc.2013-08-14ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817417020036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081741702003610817417020036

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement systemAn assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight57Pound

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8004265913info@aseptico.com

Regulatory Flags#

DUNS number
016853348
Device count
1
Serial number
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

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