FDA.reportPublic FDA data

Soan

Primary DI
03760349805335
Brand
Soan
Company
DENTALHITEC
Model
SOAN1
Catalog number
SOAN1
Device description
1 Soan handpiece1 wireless pedal1 battery charger1 power supply, 5 containers1 user manual2 boxes of dental needles C3022 (primary DI Number: 03760349800507)1 box of dental needles C3025 (primary DI Number: 03760349800521)
Published
2023-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZMNeedle, Dental
EJISyringe, Cartridge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1
EJISyringe, CartridgeDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760349809951Direct MarkingGS10
03760349805335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760349809951037603498099513760349809951
03760349805335037603498053353760349805335

GMDN Terms#

Term, Definition table
TermDefinition
Dental computer assisted anaesthesia injection unitA mains electricity (AC-powered) dental device intended to accurately administer a local anaesthetic agent within the oral cavity for improved analgesic localization and pain reduction. It is typically a bench-top unit with processing software, displays, and controls (e.g., foot-switch) intended to be used in conjunction with a dental anaesthesia cartridge, handpiece, and needle to form a complete computer assisted local anaesthetic delivery system. It is designed to measure and display fluid pressure variations at the needle tip to indicate needle location and aid anaesthetic agent injection; it may also measure fluid volumes and flow rates.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
640616736
Device count
1
Premarket exempt
true
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760349801054QUICKSLEEPER 5C_A2 US/CAQS_5C_A2QS_5C_A22025-12-22
03760349803331SleeperOne 5SO_5CSO-5C2023-08-22
03760349800507EFFITEC NEEDLE 30G EXTRA SHORTC3022C30222023-08-22
03760349800514EFFITEC NEEDLE 27G SHORTC3029C30292023-08-22
03760349800521EFFITEC NEEDLE 30G SHORTC3025C30252023-08-22
03760349809913SleeperOne 5SO_5CSO-5C2023-08-22
03760349809951SoanSOAN1SOAN12023-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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