FDA.reportPublic FDA data

T-Mixer Mix Tips Pink 5.4mm (50)

Primary DI
00815878022050
Brand
T-Mixer Mix Tips Pink 5.4mm (50)
Company
BURKHART DENTAL SUPPLY CO., THE
Model
72720801
Published
2019-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815878022050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815878022050008158780220508158780220500815878022050

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
800-562-8176customerservice@burkhartdental.com

Regulatory Flags

DUNS number
027532357
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00815878028397Burkhart Dental Supply727209812024-12-06
00815878028403Burkhart Dental Supply727209822024-12-06
00815878028410Burkhart Dental Supply727209832024-12-06
00815878028427Burkhart Dental Supply727209842024-12-06
00815878027628Burkhart Dental Supply727220272024-05-07
00815878027642Burkhart Dental Supply727220292024-05-07
00810052614458Burkhart Dental Supply727218522024-01-26
00810052614557Burkhart Dental Supply727218502024-01-26
00810052614564Burkhart Dental Supply727218482024-01-26
00810052615042Burkhart Dental Supply727218542024-01-26
00810052615899Burkhart Dental Supply727218552024-01-26
00810052616780Burkhart Dental Supply727218562024-01-26
00810052617770Burkhart Dental Supply727219622024-01-26
00810052618883Burkhart Dental Supply727219632024-01-26
00810052619873Burkhart Dental Supply727218572024-01-26
00810052619996Burkhart Dental Supply727219642024-01-26
00810052610306Burkhart Dental Supply727218402024-01-15
00810052610313Burkhart Dental Supply727218412024-01-15
00810052610320Burkhart Dental Supply727218422024-01-15
00810052610337Burkhart Dental Supply727218432024-01-15

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06438311708713LMDentalLM-DentalDZN2026-03-23
06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
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