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

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 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070164694
Device count
4
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810053600641Dri-Scope Aid - Connectors Kits - Type SD-O (100 pack)401789-412401789-4122025-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760349801054QUICKSLEEPER 5C_A2 US/CADENTALHITECEJI2025-12-22
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
08800075614407OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614421OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075624994OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075607812OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075626332OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075626349OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075626356OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075614360OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
08800075614414OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
08800053042093DENOPSDENTIS CO. ,LTDEJI2024-01-23
00840326421765AstekYoung Innovations, Inc.EJI2023-12-01
00840326421772AstekYoung Innovations, Inc.EJI2023-12-01