FDA.reportPublic FDA data

BENCO

Primary DI
00366975024947
Brand
BENCO
Company
BENCO DENTAL SUPPLY CO.
Model
5133-026
Published
2022-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KXRApplicator, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366975024947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975024947003669750249473669750249470366975024947

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015108087
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
00366975069993Sterling6694-6422025-02-26
00366975070005Sterling5259-5162025-02-26
00366975069344STERLING5259-507 2024-01-26
00366975013040STERLING5259-5072023-12-13
00366975012814STERLING4983-5662023-06-13
00366975066848OPTIMUM6032-0532023-02-21
00366975066855OPTIMUM6032-0712023-02-21
00366975066862OPTIMUM6032-0802023-02-21
00366975066879OPTIMUM6032-0992023-02-21
00366975066886OPTIMUM6032-1062023-02-21
00366975066893OPTIMUM6032-1152023-02-21
00366975066909OPTIMUM6032-1242023-02-21
00366975066916OPTIMUM6032-1332023-02-21
00366975066923OPTIMUM6032-1422023-02-21
00366975066930OPTIMUM6032-1512023-02-21
00366975066947OPTIMUM6032-1602023-02-21
00366975066954OPTIMUM6032-1792023-02-21
00366975066961OPTIMUM6032-1972023-02-21
00366975066978OPTIMUM6032-2042023-02-21
00366975066992OPTIMUM6032-2312023-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208482416OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208482423OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208590500OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208590678OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208590494OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208482768OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208488401OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208445596OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208445602OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208486254OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208445947OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
EKUR000967KA0Disposable brush tips (black)KURARAY NORITAKE DENTAL INC.KXR2025-08-22
EKUR000968KA0Disposable brush tips (white)KURARAY NORITAKE DENTAL INC.KXR2025-08-22
00883205021809Inspiral Brush TipULTRADENT PRODUCTS, INC.KXR2025-08-19
10818207025033Traxodent Gel Brush TipsVista DentalKXR2025-06-30
08800019116608NeoGlide Resin InstrumentsB& L Biotech, inc.KXR2025-06-18
08800019116615NeoGlide Resin InstrumentsB& L Biotech, inc.KXR2025-06-18
00789594000046MicrobrushYOUNG MICROBRUSH, LLCKXR2025-06-13
10789594000050MicrobrushYOUNG MICROBRUSH, LLCKXR2025-06-13
00359883002718Multi-Brush® (Yellow)DEN-MAT HOLDINGS, LLCKXR2025-03-12
00359883003449Multi-Brush® (Blue)DEN-MAT HOLDINGS, LLCKXR2025-03-12
00359883004019Temptation® 10L Syringe Mixing TipsDEN-MAT HOLDINGS, LLCKXR2025-03-12
D701T20G191Applicator TipsPULPDENT CORPORATIONKXR2024-12-03
EKUR001024KA1Applicator brush (fine<silver>)KURARAY NORITAKE DENTAL INC.KXR2024-08-26
EKUR001025KA0Applicator brush (endo<black>)KURARAY NORITAKE DENTAL INC.KXR2024-08-26
EKUR001221KA0Applicator brush (superfine<white>)KURARAY NORITAKE DENTAL INC.KXR2024-08-26
00000008857972RMORmo, Inc.KXR2024-08-12
D956DVNRSTI0DSI Veneer Stick Adhesive Tip Holders 16pcsD.S.I DENTAL SOLUTIONS LTDKXR2024-06-27
D974BSI20032BritedentBright Supply, Inc.KXR2024-06-07
20889989061455OrmcoORMCO CORPORATIONKXR2024-03-07