FDA.reportPublic FDA data

PLUNGER FOR PAROJECT-HF02500A1

Primary DI
00303620000031
Brand
PLUNGER FOR PAROJECT-HF02500A1
Company
SEPTODONT, INC
Model
01N2042
Device description
Spare part for dental cartridge syringe
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGMInjector, Jet, Mechanical-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGMInjector, Jet, Mechanical-PoweredDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904279000PAROJECT ANESTHETIC SYRINGERonvig Instruments, Ltd.1990-12-07EGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00303620000031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00303620000031003036200000313036200000310303620000031

GMDN Terms#

Term, Definition table
TermDefinition
Dental anaesthesia syringe, reusableA hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1.8Milliliter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(303) 665-7535usregulatoryaffairs@septodont.com

Regulatory Flags#

DUNS number
012925513
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00303620000628SEPTODONT ETCH 4 X 4GM KIT01C203201C20322016-09-12
00303620000635SEPTODONT USA SEPTOETCH 12-1.6GM SYR01C203401C20342016-09-12
00303620000642SEPTODONT ETCHANT 60GM SYR KIT01C203501C20352016-09-12
00303620000857SEPTODONT HZ IMAGE MH COMP L/C SYR KIT01C20802016-09-12
00303620000949SEPTODONT IMAGE MH L/C REFILL SYRINGE BW01C20932016-09-12
03760140703601R.T.R Membrane9625M2017-07-14
03760140703625R.T.R Membrane 9627O2017-07-14
03760140703618R.T.R Membrane 9626N2017-07-14
00303620000000ASPIJECT SELF ASPIRATING SYRINGE01N202001N20202016-09-15
00303620000017ASPIJECT WITH O-RING01N203001N20302016-09-15
00303620000048SEPTODONT PETITE - BLUE01N210001N21002016-09-12
00303620000055SEPTODONT FUSION(TITANIUM) SYRINGE01N21052016-09-12
00303620000062SEPTODONT STANDARD- GOLD01N211001N21102016-09-12
00303620000079SEPTODONT PINK PETITE ASPIRATING SYRINGE01N212001N21202016-09-12
00303620000086SEPTODONT ECO-A ASPIRATING SYR WINGLESS01N220001N22002016-09-12
00303620000093SEPTODONT ECO-CW ASPIRATING SYR WINGED01N221001N22102016-09-12
00303620000291EARLOOP FACE MASK BLUE 3 PLY (2115)01I21152016-09-12
00303620000307EARLOOP FACE MASK PINK 3 PLY (2116)01I21162016-09-12
00303620000314EARLOOP FACE MASK WHITE 3 PLY (2130)01I21302016-09-12
13760140703608R.T.R Membrane9625M2017-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760349801054QUICKSLEEPER 5C_A2 US/CADENTALHITECEGM2025-12-22
05713513000058PAROJECTRønvig Dental Manufacturing A/SEGM2017-08-25
00815160020580MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020610MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020627MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020634MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020641MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020658MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00303620000024PAROJECTSEPTODONT, INCEGM2016-09-15