FDA.reportPublic FDA data

Monolith Etching-Gel-Tips

Primary DI
04064896000533
Brand
Monolith Etching-Gel-Tips
Company
PRISMAN INC.
Model
M526
Published
2021-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JEWTip, Rubber, Oral Hygiene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEWTip, Rubber, Oral HygieneDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04064896000533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064896000533040648960005334064896000533

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

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
G149TBSB1280TBS BASICSACME ENTERPRISE.JEW2026-05-20
003598830024662.5 Mixing Tips with 20ga Integrated Needle 25-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
003598830024732.5 Mixing Tips with 17ga Integrated Needle 25-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
003598830024803.2 Mixing Tips with Integrated Needle 25-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
003598830024974.2 Mixing Tips with Integrated Needle 25-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003395Universal Needle Tips 18G (Pink) 100-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003401Universal Needle Tips 20G (Black) 100-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003418Universal Needle Tips 22G (Grey) 100-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003425Universal Needle Tips 25G (Blue) 100-PackDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883003432Flocked Needle Tips (Black)DEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883004118Clinician's Choice® Needle Tubes & PlugsDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCJEW2025-03-12
00359883005221Max Etch 35% Phosphoric Acid Etch 5mLDEN-MAT HOLDINGS, LLCJEW2025-03-12
05061035460486Love NoobsROBUST VENTURES LTDJEW2024-11-29
08806383565608DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383565615DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383565660DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383565677DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383586696DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-27
08806383561921DISPOSABLE TIPSDiaDent Group InternationalJEW2023-06-26
10818207024005Vista Pocket ProbeVista DentalJEW2022-09-01
075401720190022.5 Mixing Tips with 20ga Integrated Needle (Brown)CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2022-03-24
07540172002240Clinician's Choice® High Viscosity Tubes & PlugsCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-22
07540172002257Clinician's Choice® Low Viscosity Tubes & PlugsCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-22
07540172002264Clinician's Choice® Needle Tubes & PlugsCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-22
075401720006042.5 Mixing Tips with Integrated NeedleCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
075401720006113.2 Mixing Tips with Integrated NeedleCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
075401720006284.2 Mixing Tips with Integrated NeedleCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
07540172001601Universal Needle Tips (Pink)CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21
07540172001618Universal Needle Tips (Black)CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.JEW2020-10-21