FDA.reportPublic FDA data

3.2 Mixing Tips with Integrated Needle

Primary DI
07540172000611
Brand
3.2 Mixing Tips with Integrated Needle
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
032253
Catalog number
032253
Device description
Dental material mixing nozzle, non-sterile
Published
2020-10-21
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

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
07540172000611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540172000611075401720006117540172000611

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing nozzle, non-sterileA non-sterile device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter3.2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags#

DUNS number
626406016
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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#

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07540172019514Evanesce™ Nano-Enhanced Universal Restorative A2U Single Dose Sample9732129732122024-09-17
07540172019644Evanesce™ Silk Nano-Enhanced Universal Restorative A1E Single Dose3235703235702024-09-17
07540172019651Evanesce™ Silk Nano-Enhanced Universal Restorative A2E Single Dose3235713235712024-09-17
07540172019668Evanesce™ Silk Nano-Enhanced Universal Restorative A3E Single Dose3235723235722024-09-17
07540172019675Evanesce™ Silk Nano-Enhanced Universal Restorative B1E Single Dose3235733235732024-09-17
07540172019682Evanesce™ Silk Nano-Enhanced Universal Restorative A2D Single Dose3235743235742024-09-17
07540172019699Evanesce™ Silk Nano-Enhanced Universal Restorative A3D Single Dose3235753235752024-09-17
07540172019705Evanesce™ Silk Nano-Enhanced Universal Restorative B2U Single Dose3235763235762024-09-17
07540172019712Evanesce™ Silk Nano-Enhanced Universal Restorative C2U Single Dose3235773235772024-09-17
07540172019729Evanesce™ Silk Nano-Enhanced Universal Restorative A2U Single Dose Sample9732119732112024-09-17
07540172019507MPa Universal™ Light-Cure Universal Adhesive Unit Dose Sample9732669732662024-08-09
07540172019392EdgeDam™ Refill Heavy 6x6 Latex-FreeEDVLFH6650EDVLFH66502024-06-04
07540172019408EdgeDam™ Refill Heavy 5x5 Latex-FreeEDVLFH5550EDVLFH55502024-06-04
07540172019415EdgeDam™ Refill Medium 6x6 Latex-FreeEDVLFM6650EDVLFM66502024-06-04
07540172019422EdgeDam™ Refill Medium 5x5 Latex-FreeEDVLFM5550EDVLFM55502024-06-04
07540172019439EdgeDam™ Refill Heavy 6x6 LatexEDBLH6636EDBLH66362024-06-04
07540172019446EdgeDam™ Refill Heavy 5x5 LatexEDBLH5552EDBLH55522024-06-04
07540172019453EdgeDam™ Refill Medium 6x6 LatexEDBLM6636EDBLM66362024-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00359883003418Universal Needle Tips 22G (Grey) 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
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
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
07540172001625Universal Needle Tips (Grey)CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
07540172001632Universal Needle Tips (Blue)CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
07540172001649Universal Needle Tips (Black)CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21