FDA.reportPublic FDA data

Strip Placer

Primary DI
08961104622142
Brand
Strip Placer
Company
MELPEX BEAUTY INSTRUMENTS
Model
Strip Placer
Catalog number
16-261A
Device description
Strip Placer
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJBHandle, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08961104622142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08961104622142089611046221428961104622142

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive strip, single-useA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.

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
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
08961104622159polar bear Martensitic positionerMartensitic positioner16-2612026-05-21
08961104622166Positive PositionerPositive Positioner16-2602026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB3100TBS BASICSACME ENTERPRISE.EJB2026-05-16
08809260472853TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472860TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472877TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472884TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472891TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472907TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472914TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472921TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
G149NP360100NPSACME ENTERPRISE.EJB2026-05-01
G149NP380630NPSACME ENTERPRISE.EJB2026-05-01
EZPF26179500HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179510HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179550HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179560HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179570HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179580HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179590HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
10371347017721Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
10371347017745Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
08800075626905OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627230OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627247OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627254OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627674OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627681OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627735OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627742OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627759OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08809823986223Abutment RemoverEBI Inc.EJB2025-10-02