FDA.reportPublic FDA data

JMU

Primary DI
00840456224885
Brand
JMU
Company
JMU DENTAL, INC
Model
41012255
Device description
JMU Ultrasonic Scaler Tip, Model P3, Compatible with EMS/Woodpecker-Type Handpieces, 5 Tips/Box. Sold by Box.
Published
2026-09-30
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
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840456224885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456224885008404562248858404562248850840456224885

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, periodontalAn insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081258380
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840456225424JMU368150012026-10-14
00840456225431JMU368150022026-10-14
00840456225332JMU369430022026-10-13
00840456225349JMU369430032026-10-13
00840456225394JMU463070032026-10-13
00840456225400JMU361020042026-10-13
00840456225417JMU361020052026-10-13
00840456225271JMU520210022026-10-12
00840456224656JMU229080452026-10-09
00840456224663JMU229080462026-10-09
00840456224670JMU229080472026-10-09
00840456224687JMU229080482026-10-09
00840456224694JMU229080492026-10-09
00840456224700JMU229080502026-10-09
00840456224717JMU229080512026-10-09
00840456224724JMU229080522026-10-09
00840456224731JMU229080532026-10-09
00840456225264JMU520210012026-10-09
00840456224861JMU410122532026-09-30
00840456224878JMU410122542026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456224861JMUJMU DENTAL, INCEMN2026-09-30
00840456224878JMUJMU DENTAL, INCEMN2026-09-30
00840456224892JMUJMU DENTAL, INCEMN2026-09-30
00840456224908JMUJMU DENTAL, INCEMN2026-09-30
00840456224915JMUJMU DENTAL, INCEMN2026-09-30
06973042242995Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243008Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243015Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243022Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243039Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243046Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243053Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243060Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243077Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243084Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243091Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243107Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243114Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243121Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243138Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243145Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243152Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243169Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243176Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243183Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243190Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243206Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243213Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243220Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243237Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30