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
D813CR11010Nuance®CR1101CR11012016-09-24
D813CR11020Nuance®CR1102CR11022016-09-24
D813CR11030Nuance®CR1103CR11032016-09-24
D813CR11040Nuance®CR1104CR11042016-09-24
D813CR11060Nuance®CR1106CR11062016-09-24
D813CR11080Nuance®CR1108CR11082016-09-24
D813CR11120Nuance®CR1112CR11122016-09-24
D813CR11210Nuance®CR1121CR11212016-09-24
D813CR11350Nuance®CR1135CR11352016-09-24
D813CR11360Nuance®CR1136CR11362016-09-24
D813CR11370Nuance®CR1137CR11372016-09-24
D813CR11380Nuance®CR1138CR11382016-09-24
D813CR11400Nuance®CR1140CR11402016-09-24
D813CR11420Nuance®CR1142CR11422016-09-24
D813CR11430Nuance®CR1143CR11432016-09-24
D813CR11460Nuance®CR1146CR11462016-09-24
D813CR11550Nuance®CR1155CR11552016-09-24
D813CR12090Nuance®CR1209CR12092016-09-24
D8130303761050GBLOCK0303761052023-03-06
D8130303761100GBLOCK0303761102023-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB1280TBS BASICSACME ENTERPRISE.JEW2026-05-20
003598830024662.5 Mixing Tips with 20ga Integrated Needle 25-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
003598830024732.5 Mixing Tips with 17ga Integrated Needle 25-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
003598830024803.2 Mixing Tips with Integrated Needle 25-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
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
00359883004118Clinician's Choice® Needle Tubes & PlugsDEN-MAT HOLDINGS, LLCJEW2025-03-12
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
08806383565608DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383565615DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383565660DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383565677DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383586696DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383561921DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-26
10818207024005Vista Pocket ProbeVista DentalJEW2022-09-01
075401720190022.5 Mixing Tips with 20ga Integrated Needle (Brown)CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2022-03-24
04064896000533Monolith Etching-Gel-TipsPRISMAN INC.JEW2021-11-02
07540172002240Clinician's Choice® High Viscosity Tubes & PlugsCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-22
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