FDA.reportPublic FDA data

Acrylic C&B dispensing gun

Primary DI
D72310205800
Brand
Acrylic C&B dispensing gun
Company
SAFCO DENTAL SUPPLY CO.
Model
1020580
Catalog number
1020580
Device description
Safco C&B Acrylic gun w/ 10:1 plunger
Published
2022-11-22
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
false

Product Codes#

Code, Name table
CodeName
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D72310205800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material cartridge-plunging applicator, two-component, manualA hand-held manual device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is typically a pistol-like device with a cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
020417380
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20810063756240KIDS BUDDY Toothbrush8250071TK32025-03-19
20810063756257Power Curve Toothbrush82500830022025-03-19
20810063756264Esprit Ultra Fine Toothbrush82500872082025-03-19
20810063756271Whisper Tech Ultra-Fine Toothbrush82500926012025-03-19
20810063756288Power Curve Toothbrush8250093002-I2025-03-19
20810063756400Power Curve Extra-Soft Toothbrush8250094002XS2025-03-19
20810063756431KIDS BUDDY Toothbrush8250072TK3-I2025-03-19
20810063756585Jr Series Comfort Grip Toothbrush82500892402025-03-19
20810063756592Power Curve Extra-Soft Toothbrush8250095002XS-I2025-03-19
20810063755564Waxed Dental Floss8250016300062025-03-18
20810063756172Euro Tech Compact Sensitive Toothbrush8250007T1872025-03-18
20810063756189Waxed Dental Floss8250017300072025-03-18
20810063756196Floss Picks8250039FP2025-03-18
20810063756202Endeavor Toothbrush8250043T0202025-03-18
20810063756219Vital Fresh Toothbrush8250048T056-I2025-03-18
20810063756226Aspire Compact Toothbrush8250060T509-I2025-03-18
20810063756233PlaquePRO Interdental Proxy Brush8250066T5132025-03-18
20810063756394Polisher Compact Toothbrush8250058T4902025-03-18
20810063756530Soft Flex Toothbrush8250054T183-I2025-03-18
20810063756547Glisten Junior Toothbrush8250064T511-I2025-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481135309MICROPRIMEZest Anchors, LLCEID2026-03-10
00840479201115CR MARK II SYRINGERELIANCE ORTHODONTIC PRODUCTS INCEID2026-02-27
00304040194782Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00304040194799Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00304040194805Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00371347019889Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
00841336104877Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104891Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104907Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104914Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00810126504357Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEID2025-12-16
00810126504388Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEID2025-12-16
00371347017786Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902265DX-MixerDXM CO., LTDEID2025-09-29
20840326424302DefendYoung Innovations, Inc.EID2025-09-05
00883205032041ExperTempULTRADENT PRODUCTS, INC.EID2025-08-23
E217172261Mixing TipsKettenbach GmbH & Co. KGEID2025-08-14
E239D49701X41Mixing tipsDreve Dentamid GmbHEID2025-08-13
00195062154119Kerr RestorativesKerr CorporationEID2025-08-08
00195062154126Kerr RestorativesKerr CorporationEID2025-08-08
00195062154133Kerr RestorativesKerr CorporationEID2025-08-08
00195062154140Kerr RestorativesKerr CorporationEID2025-08-08
00195062154157Kerr RestorativesKerr CorporationEID2025-08-08
00195062154164Kerr RestorativesKerr CorporationEID2025-08-08
E239D496041TipsDreve Dentamid GmbHEID2025-07-21
E239D49701X61Mixing tipsDreve Dentamid GmbHEID2025-07-18
00359883007201EVANESCEDEN-MAT HOLDINGS, LLCEID2025-05-30
00813909013350Dental Cartridge DispenserNOVABONE PRODUCTS, LLCEID2025-04-25
E217150221Application TipsKettenbach GmbH & Co. KGEID2025-04-03
E217150231Application TipsKettenbach GmbH & Co. KGEID2025-04-03