FDA.reportPublic FDA data

DISPENSING GUN 2 (1:1/2:1)

Primary DI
J014660019700
Brand
DISPENSING GUN 2 (1:1/2:1)
Company
Kulzer GmbH
Model
66001970
Catalog number
66001970
Device description
Instruments, Dental Hand
Published
2024-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J014660019700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Syringe dispensing gun, reusableA hand-held, manually-operated device intended to facilitate the infusion/dispensing of a high viscosity fluid or pressurized liquid (e.g., laminar stream) by assisting with the advancement of the syringe plunger. It includes a manually-squeezed lever mechanism (e.g., pistol-like) and is designed to accept a standard syringe (not included) whereby it is intended to increase the amount of force the user can apply to the syringe plunger based on leverage. It is not foot-operated and does not include a rotating crank mechanism. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)431-1785customerservice.na@kulzer-dental.com

Regulatory Flags#

DUNS number
315666321
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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J014660872150Retraxil blue66087215660872152026-04-21
J014661012760Retraxil blue66101276661012762026-04-21
J014661012770Retraxil blue66101277661012772026-04-21
J014661012780Retraxil blue66101278661012782026-04-21
J014660164550Starlight pro66016455660164552026-01-28
J014660573650Starlight pro66057365660573652026-01-28
J014660968300Starlight pro66096830660968302026-01-28
J014660969290Starlight pro66096929660969292026-01-28
J014660971690Starlight pro66097169660971692026-01-28
J014660971700Starlight pro66097170660971702026-01-28
J014661002680VENUS Diamond FLOW66100268661002682024-10-24
J014661002690VENUS Diamond FLOW66100269661002692024-10-24
J014661002700VENUS Diamond FLOW66100270661002702024-10-24
J014661002710VENUS Diamond FLOW66100271661002712024-10-24
J014661002720VENUS Diamond FLOW66100272661002722024-10-24
J014661002730VENUS Diamond FLOW66100273661002732024-10-24
J014661002740VENUS Diamond FLOW66100274661002742024-10-24
J014661002750VENUS Diamond FLOW66100275661002752024-10-24
J014661003060VENUS Diamond FLOW66100306661003062024-10-24

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Primary DI, Brand, Company table
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