FDA.reportPublic FDA data

Lux-Perio

Primary DI
08961104675018
Brand
Lux-Perio
Company
MELPEX BEAUTY INSTRUMENTS
Model
slightly curved tip, 3.0 mm / 5.0 mm
Catalog number
325-348KE1
Device description
Reusable Lux-Perio Root Elevator, slightly curved tip, 3.0 mm / 5.0 mm, 160 mm length, non-sterile.
Published
2026-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMJElevator, Surgical, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08961104675018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08961104675018089611046750188961104675018

GMDN Terms#

Term, Definition table
TermDefinition
Dental elevator, tooth/rootA hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length6.29Inch
Length160Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645674404
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08961104621824Mathieu Standard TipDouble Spring15-006D2026-05-21
08961104621831Mathieu Standard TipSingle Spring15-006S2026-05-21
08961104621848Mathieu Standard Tip TCDouble Spring15-006DTC2026-05-21
08961104621855Mathieu Standard Tip TCSingle Spring15-006STC2026-05-21
08961104621862Mathieu Narrow TipDouble Spring15-002D2026-05-21
08961104621879Mathieu Narrow TipSingle Spring15-002S2026-05-21
08961104621886Mathieu Narrow Tip TCDouble Spring15-002DTC2026-05-21
08961104621893Mathieu Narrow Tip TCSingle Spring15-002STC2026-05-21
08961104621909Mathieu Narrow Tip HalfDouble Spring15-016D2026-05-21
08961104621916Mathieu Narrow Tip HalfSingle Spring15-016S2026-05-21
08961104621923Mathieu Hook TipDouble Spring15-014D2026-05-21
08961104621930Mathieu Hook TipSingle Spring15-014S2026-05-21
08961104621947Mathieu Hole TipDouble Spring15-008D2026-05-21
08961104621954Mathieu Hole TipSingle Spring15-008S2026-05-21
08961104621961Mathieu Hook Tip GroovedDouble Spring15-014GD2026-05-21
08961104621978Mathieu Hook Tip GroovedSingle Spring15-014GS2026-05-21
08961104621985Mathieu Smaha Ultra Fine TipSingle Spring20-020S 2026-05-21
08961104621992Mathieu Smaha Ultra Fine TipDouble Spring20-020D2026-05-21
08961104622142Strip PlacerStrip Placer16-261A2026-05-21
08961104622159polar bear Martensitic positionerMartensitic positioner16-2612026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7540TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7550TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7560TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7570TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7580TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7590TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7600TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7610TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7620TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7630TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7640TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7650TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7660TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7670TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7680TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7690TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7700TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7710TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7830TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7840TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7850TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149NP380810NPSACME ENTERPRISE.EMJ2026-05-01
G149NPPMH0NPSACME ENTERPRISE.EMJ2026-05-01
08961104674998Lux-PerioMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675001Lux-PerioMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675025LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675032LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675049LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675056LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675063LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27