FDA.reportPublic FDA data

QUICKSLEEPER 5C_A2 US/CA

Primary DI
03760349801054
Brand
QUICKSLEEPER 5C_A2 US/CA
Company
DENTALHITEC
Model
QS_5C_A2
Catalog number
QS_5C_A2
Device description
1 QuickSleeper 5 handpiece and control box 1 wireless pedal 1 power cable 1 power supply, 6 containers 1 user manual 1 box of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521) 1 box of dental needles C3029 (primary DI Number: 03760349800514)
Published
2025-12-22
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
EGMInjector, Jet, Mechanical-Powered
EJISyringe, Cartridge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGMInjector, Jet, Mechanical-PoweredDental2
EJISyringe, CartridgeDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760349809715Direct MarkingGS10
03760349801054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760349809715037603498097153760349809715
03760349801054037603498010543760349801054

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.

Regulatory Flags#

DUNS number
640616736
Device count
1
DM exempt
false
Premarket exempt
false
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
03760349805335SoanSOAN1SOAN12023-08-22
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
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
00840326422670AstekYoung Innovations, Inc.EJI2025-10-10
00840326423691AstekYoung Innovations, Inc.EJI2025-10-10
00840326422687AstekYoung Innovations, Inc.EJI2025-05-27
00840326423707AstekYoung Innovations, Inc.EJI2025-05-27
00840326422663AstekYoung Innovations, Inc.EJI2025-05-27
00840326423684AstekYoung Innovations, Inc.EJI2025-05-27
00840326423721AstekYoung Innovations, Inc.EJI2025-05-27
05713513001185ASPIJECT Active CompactRønvig Dental Manufacturing A/SEJI2025-02-27
05060212052117Dental Syringe 85mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
05060212052124Dental Syringe Long 115mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
05060212057518Dental Syringe 85mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
05060212057525Dental Syringe Long 115mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
00813677022882PDT, Inc.PDT, INC.EJI2024-07-01
00813677022905PDT, Inc.PDT, INC.EJI2024-07-01
00813677022899PDT, Inc.PDT, INC.EJI2024-06-27
08800075607799OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614391OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614360OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
08800075614414OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
00840326421765AstekYoung Innovations, Inc.EJI2023-12-01