FDA.reportPublic FDA data

Soan

Primary DI
03760349805335
Brand
Soan
Company
DENTALHITEC
Model
SOAN1
Catalog number
SOAN1
Device description
1 Soan handpiece 1 wireless pedal 1 battery charger 1 power supply, 5 containers 1 user manual 2 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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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 anaesthesia electronic injectorAn electrically-powered dental device intended to accurately administer a local anaesthetic agent within the oral cavity for improved analgesic localization and pain reduction. It is in the form of a standalone hand-held unit or a benchtop unit with a handpiece and is intended to be used with a dedicated cartridge and needle (not included). It may be 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 Temperature00

Regulatory Flags#

DUNS number
640616736
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08053610773750EFFITECC3200_USC3200_US2026-08-06
03760349803331SleeperOne 5SO_5CSO-5C2023-08-22
03760349801054QUICKSLEEPER 5C_A2 US/CAQS_5C_A2QS_5C_A22025-12-22
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
G8791002840DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G8791002970DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100297A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100297B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100297C0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G8791003020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100302B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G8791003130DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100313B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G87910032910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
08053610773750EFFITECDENTALHITECDZM2026-08-06
08053610773781EFFITECTECNOFAR SPADZM2026-07-30
08053610773798EFFITECTECNOFAR SPADZM2026-07-30
08053610773804EFFITECTECNOFAR SPADZM2026-07-30
00841013124648MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.DZM2026-06-26
00841013124655MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.DZM2026-06-26
00841013124686MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.DZM2026-06-26
D832BLT100501PlasdentPLASDENT CORPORATIONDZM2026-05-28
D1250802Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250812Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250822Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10012Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10022Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10072Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10122Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
20192253037422MonojectCardinal Health 200, LLCDZM2026-04-02
20192253037446MonojectCardinal Health 200, LLCDZM2026-04-02
20192253037484MonojectCardinal Health 200, LLCDZM2026-04-02
20192253037507MonojectCardinal Health 200, LLCDZM2026-04-02
20192253037439MonojectCardinal Health 200, LLCDZM2026-02-10