FDA.reportPublic FDA data

CompuDent STA

Primary DI
20618874000015
Brand
CompuDent STA
Company
TRICOR SYSTEMS, INC.
Model
STA-5110
Device description
STA Instrument
Published
2018-01-26
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
EJISyringe, Cartridge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJISyringe, CartridgeDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061904000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061904000COMPUDENT STAMilestone Scientific, Inc.2006-08-08EJI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20618874000015PrimaryGS10
10618874000011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061887400001520618874000015
1061887400001110618874000011

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
070164694
Device count
4
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
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
00618874000011CompuDent STASTA-51102018-01-26
00810053601013Dri-Scope Aid - Cabinet - Cetacea Ext Port Tubings, 30 in (2 pack)DS-340-30DS-340-302025-05-02
00810053601020Dri-Scope Aid - Cabinet - Tubing Management Strip, Series 23401998-109401998-1092025-05-02
00810053601037Dri-Scope Aid - Cabinet - Tubing Management Strip, Series 33401998-110401998-1102025-05-02
00810053601044Dri-Scope Aid - Cabinet - Interface Cable, 70 in401998-235-70401998-235-702025-05-02
00810053601051Dri-Scope Aid - Cabinet - Interface Cable, 112 in401998-235-112401998-235-1122025-05-02
00810053601068Dri-Scope Aid (DSA/DSA2/Jet-Stream) - Replacement Caps (1 pack)401789-315401789-3152025-05-02
00810053601075Dri-Scope Aid (DSA/DSA2) - Filter Kit (5 pack)401789-404-1401789-404-12025-05-02
00810053601082Dri-Scope Aid (DSA/DSA2) - Filter Kit (1 pack)401789-304401789-3042025-05-02
00810053601099Dri-Scope Aid - AC Power Cord, 12 ft401998-147-12401998-147-122025-05-02
00810053600009Dri-Scope Aid - Cabinet - Power Supply (w/6 ft cord)401998-146401998-1462025-03-25
00810053600948Dri-Scope Aid - TRACKER - Hub, USB, Powered406454-106-2406454-106-22025-03-25
00810053600955Dri-Scope Aid - TRACKER - Power Strip, 6 Outlet406454-107-2406454-107-22025-03-25
00810053600962Dri-Scope Aid - Cabinet (or TRACKER) - High Mount KitDS-HMKDS-HMK2025-03-25
00810053600979Dri-Scope Aid - Cabinet (or TRACKER) - Kink Prevention KitDS-KPKDS-KPK2025-03-25
00810053600986Dri-Scope Aid - Jet-Stream - Mounting Bracket Kit402119-111-TSI402119-111-TSI2025-03-25
00810053600993Dri-Scope Aid - Pole Mount, Clamp & Mounting Hardware401789-181401789-1812025-03-25
00810053601006Dri-Scope Aid - Power Supply (w/6 ft cord)401789-146401789-1462025-03-25
00810053600016Dri-Scope Aid - Connectors Kits - Type P (100 pack)401789-409401789-4092025-03-14
00810053600610Dri-Scope Aid - Connectors Kit - Type P (1 pack)401789-309401789-3092025-03-14

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
03760349801054QUICKSLEEPER 5C_A2 US/CADENTALHITECEJI2025-12-22
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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