FDA.reportPublic FDA data

Monolith Syringe

Primary DI
04064896000540
Brand
Monolith Syringe
Company
PRISMAN INC.
Model
M527
Published
2021-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04064896000540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064896000540040648960005404064896000540

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solution syringeA hand-held, manual dental instrument consisting of a barrel (cylinder) with plunger intended to be used to dispense dental etching solution (etchant) to a patient’s tooth/teeth. It is intended to be filled once and used on multiple patients; disposable dispensing tips may be included. This device is reusable until the contents of the syringe are exhausted.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117569946
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04064896000557PWR Classic Powder MintAP-CM2024-10-24
04064896000595PWR Perio Powder MintAP-PM2024-10-24
04064896000618PWR Perio Powder NeutralAP-PN2024-10-24
04064896000571PWR Classic Powder NeutralAP-CN2024-10-24
04064896000014Air SupraUS-FRESH2024-07-28
04064896000038Air SupremeUS-PLUS2024-07-28
04064896000106"Monolith Prophy Paste Xtra COARSE ""Spearmint"" Tube"M5052021-10-10
04064896000113"Monolith Prophy Paste MEDIUM ""Spearmint"" Cup"M5042021-10-10
04064896000120"Monolith Prophy Paste SENSO ""BerryLime"" Tube"M5072021-10-10
04064896000137"Monolith Prophy Paste Xtra COARSE ""Spearmint"" Cup"M5062021-10-10
04064896000151"Monolith Prophy Paste SENSO ""Spearmint"" Tube"M5012021-10-10
04064896000168"Monolith Prophy Paste MEDIUM ""Spearmint"" Tube"M5032021-10-10
04064896000175"Monolith Prophy Paste SENSO ""Spearmint"" Cup"M5022021-10-10
04064896000366"Monolith Prophy Paste SENSO ""BerryLime"" Cup"M5082021-10-10
04064896000373"Monolith Prophy Paste MEDIUM ""BerryLime"" Tube"M5092021-10-10
04064896000380"Monolith Prophy Paste MEDIUM ""BerryLime"" Cup"M5102021-10-10
04064896000397"Monolith Prophy Paste Xtra COARSE ""BerryLime"" Tube"M5112021-10-10
04064896000403"Monolith Prophy Paste Xtra COARSE ""BerryLime"" Cup"M5122021-10-10
04064896000410Monolith Prophy Paste ZIRCOM5132021-10-10
04064896000441"Monolith Prophy Powder Genie Smile TOP ""Spearmint"""M5142021-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10304040194789Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194796Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194802Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10371347019886Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
10371347017783Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902203DX-MixerDXM CO., LTDEID2025-09-29
08056000372298Dynamic-static Mixing TipsZHERMACK SPAEID2025-03-28
08056000372304Mixing TipsZHERMACK SPAEID2025-03-28
08056000372311Mixing TipsZHERMACK SPAEID2025-03-28
08056000372328Mixing TipsZHERMACK SPAEID2025-03-28
J014656875140IOT white 96Kulzer GmbHEID2024-09-09
J014660007820IOT yellow 96Kulzer GmbHEID2024-09-09
J014660009050BITE REG INTRAORAL TIP CD 96Kulzer GmbHEID2024-09-09
J014660019880Mixing Tip yellow 1:1 48Kulzer GmbHEID2024-09-09
J014660019890Mixing Tip green 1:1 48Kulzer GmbHEID2024-09-09
08800017901923DX-MixerDXM CO., LTDEID2024-06-04
08800017901978DX-MixerDXM CO., LTDEID2024-06-04
08800017902005DX-MixerDXM CO., LTDEID2024-06-04
08800017902029DX-MixerDXM CO., LTDEID2024-06-04
10810339032064SAFE DENTBGSS Company Inc.EID2024-05-01
07615208353730Clinical Accessory (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-10-25
08800017901893Dynamic MixerDXM CO., LTDEID2023-10-25
08800017901879Dynamic MixerDXM CO., LTDEID2023-10-24
08800017901848DX-MixerDXM CO., LTDEID2023-07-31
08800017901657DX-MixerDXM CO., LTDEID2023-07-26
00020221017809EXEL 1mL CARRYING AND DELIVERY SYRINGEExel InternationalEID2023-04-21
07615208339932CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
07615208379297CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
10371347010845Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-15
10371347008620Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-10