FDA.reportPublic FDA data

Universal Needle Tips 22G (Grey) 100-Pack

Primary DI
00359883003418
Brand
Universal Needle Tips 22G (Grey) 100-Pack
Company
DEN-MAT HOLDINGS, LLC
Model
112122
Catalog number
112122
Device description
Dental material injection cannula, single-use
Published
2025-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEWTIP, RUBBER, ORAL HYGIENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEWTip, Rubber, Oral HygieneDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00359883003418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00359883003418003598830034183598830034180359883003418

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge22Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature
Storage Environment Temperature025 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)433-6628info@denmat.com

Regulatory Flags#

DUNS number
809857704
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8130303761050GBLOCK0303761052023-03-06
D8130303761100GBLOCK0303761102023-03-06
00359883007218EVANESCE0322200322202025-10-08
00359883005214Max Etch 35% Phosphoric Acid Etch 30mL3453023453022025-03-12
00359883005221Max Etch 35% Phosphoric Acid Etch 5mL3455033455032025-03-12
D8130301255000Ceri-Prime0301255000301255002016-09-24
D8130304025501Cerinate®0304025500304025502016-09-24
D8131002AB0Ceri-Prime1002AB1002AB2016-09-24
D8131398B0Ceri-Prime1398B1398B2016-09-24
D81313990Ceri-Prime139913992016-09-24
D813402022B0Other402022B402022B2016-09-24
D8134020600Ceri-Prime4020604020602016-09-24
D81340213100Ceri-Prime402131040213102016-09-24
00359883007201EVANESCE0322550322552025-05-30
00359883005665Tissue Goo™ Hemostatic Gel 4-Pack6419046419042025-03-18
00359883005672Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit6419606419602025-03-18
00359883002053Affinity™ Heavy Body RS 120ml 2-Pack0234010234012025-03-14
00359883002046Affinity™ Heavy Body RS 120ml 2-Pack0234010234012025-03-14
00359883006273Final Shine Cotton Polishing Wheel 50-Pack1335001335002025-03-13
00359883006501Clinician's Choice® G5 Sample Pack9726059726052025-03-13

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Primary DI, Brand, Company table
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003598830024974.2 Mixing Tips with Integrated Needle 25-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003395Universal Needle Tips 18G (Pink) 100-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003401Universal Needle Tips 20G (Black) 100-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003425Universal Needle Tips 25G (Blue) 100-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003432Flocked Needle Tips (Black)DEN-MAT HOLDINGS, LLCJEW2025-03-12
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00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883005221Max Etch 35% Phosphoric Acid Etch 5mLDEN-MAT HOLDINGS, LLCJEW2025-03-12
05061035460486Love NoobsROBUST VENTURES LTDJEW2024-11-29
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07540172002257Clinician's Choice® Low Viscosity Tubes & PlugsCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-22
07540172002264Clinician's Choice® Needle Tubes & PlugsCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-22
075401720006042.5 Mixing Tips with Integrated NeedleCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
075401720006113.2 Mixing Tips with Integrated NeedleCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
075401720006284.2 Mixing Tips with Integrated NeedleCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
07540172001601Universal Needle Tips (Pink)CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
07540172001618Universal Needle Tips (Black)CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21