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
00840456224861JMU410122532026-09-30
00840456224878JMU410122542026-09-30
00840456224892JMU410122562026-09-30
00840456224908JMU410122572026-09-30
00840456224915JMU410122582026-09-30
00840456225097JMU230060012026-09-30
00840456225103JMU230060022026-09-30
00840456225110JMU230060032026-09-30
00840456225165JMU463070022026-09-18
00840456201336JMU353540242026-08-18
00840456201343JMU353540252026-08-18
00840456201350JMU353540262026-08-18
00840456201367JMU353540272026-08-18
00840456201374JMU353540282026-08-18
00840456201381JMU353540292026-08-18
00840456201398JMU353540302026-08-18
00840456201404JMU353540312026-08-18
00840456201411JMU353540322026-08-18
00840456203163JMU170090042026-08-18
00840456207123JMU170090012026-08-18

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
G879102177H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102184H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G8791021850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102185H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102186H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102187H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102191H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102196H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102197H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102211H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102212H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102213H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G8791024050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102RM340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
04963931271214NAYDM CORPORATIONEMN2026-07-09
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04963931271290NAYDM CORPORATIONEMN2026-07-09
04963931271306NAYDM CORPORATIONEMN2026-07-09
G149TBSB5010TBS BASICSACME ENTERPRISE.EMN2026-05-20