FDA.reportPublic FDA data

PiezoImplant System

Primary DI
D894SK080
Brand
PiezoImplant System
Company
Rex Implants, Inc.
Model
Removal Carrier TL 2.9
Catalog number
SK-08
Device description
Removal Carrier TL 2.9
Published
2022-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D894SK080PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant extractorA manually-operated, one-piece dental device intended to be used to retrieve an in situ dental implant [i.e., anchorage and/or retention (abutment) component], typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. It typically has a cylindrical design and a cavity or threaded shaft at the working distal end intended to grip or be inserted into the implant. It may have a handle at the proximal end or be used in conjunction with a drill and/or a separate handle or wrench (not included); it is not a collection of devices (i.e., not a kit). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6146538429info@reximplants.com

Regulatory Flags#

DUNS number
080746478
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D894B2094C0PiezoImplant SystemREX BL 2.9 x 4 H9B2-094C2022-12-24
D894B2095C0PiezoImplant SystemREX BL 2.9 x 5 H9B2-095C2022-12-24
D894B2114C0PiezoImplant SystemREX BL 2.9 x 4 H11B2-114C2022-12-24
D894B2115C0PiezoImplant SystemREX BL 2.9 x 5 H11B2-115C2022-12-24
D894B2134C0PiezoImplant SystemREX BL 2.9 x 4 H13B2-134C2022-12-24
D894B2135C0PiezoImplant SystemREX BL 2.9 x 5 H13B2-135C2022-12-24
D894B2154C0PiezoImplant SystemREX BL 2.9 x 4 H15B2-154C2022-12-24
D894B2155C0PiezoImplant SystemREX BL 2.9 x 5 H15B2-155C2022-12-24
D894R4040PiezoImplant SystemRetention Screw BL 2.9R4-042022-12-30
D894R4050PiezoImplant SystemStraight Abutment BL 2.9 H1R4-052022-12-30
D894R4060PiezoImplant SystemStraight Abutment BL 2.9 H2R4-062022-12-30
D894R4070PiezoImplant SystemStraight Abutment BL 2.9 H3R4-072022-12-30
D894R4080PiezoImplant SystemCover Screw BL 2.9R4-082022-12-30
D894R4090PiezoImplant SystemImpression Pin L BL 2.9R4-092022-12-30
D894R4100PiezoImplant SystemImpression Pin S BL 2.9R4-102022-12-30
D894R4120PiezoImplant SystemLab Analog BL 2.9R4-122022-12-30
D894R4130PiezoImplant SystemHealing Abutment BL 2.9 H1R4-132022-12-30
D894R4140PiezoImplant SystemHealing Abutment BL 2.9 H2R4-142022-12-30
D894R4150PiezoImplant SystemHealing Abutment BL 2.9 H3R4-152022-12-30
D894R4160PiezoImplant SystemHealing Abutment BL 2.9 H4R4-162022-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995226457SLEEVE FOR SURGICAL GUIDEØ5.1MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226464SLEEVE FOR SURGICAL GUIDE Ø5.1MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226471SLEEVE FOR SURGICAL GUIDE Ø3.9MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226488SLEEVE FOR SURGICAL GUIDE Ø3.9MM OPENSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226495SLEEVE FOR SURGICAL GUIDE Ø5.1MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226501SLEEVE FOR SURGICAL GUIDE Ø5.1MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226518SLEEVE FOR SURGICAL GUIDE Ø3.9MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226525SLEEVE FOR SURGICAL GUIDE Ø3.9MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226532SLEEVE FOR FIXER GUIDE Ø2.0MM PALATALSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226556SLEEVE FOR FIXER GUIDE Ø2.0MM PALATALSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995226563SLEEVE FOR FIXER GUIDE Ø1.4MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234346DRIVER RATCHET IMP. MT16° GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234353DRIVER RATCHET IMP. MT16° GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234360DRIVER HANDP. IMP. MT16° GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234377DRIVER HANDP. IMP. MT16° GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234391ANALOG REVERSE MICRO MINI ABUT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234407ANALOG REVERSE MINI ABUT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234414ANALOG REVERSE CM11.5°Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234421ANALOG REVERSE MT16°Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234438ANALOG REVERSE ABUT MULT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234445ANALOG HYBRIDO ABUT UNIV Ø4.5X6MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234452ANALOG HYBRIDO ABUT UNIV Ø4.5X4MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234469ANALOG HYBRIDO ABUT UNIV Ø3.3X6MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234476ANALOG HYBRIDO ABUT UNIV Ø3.3X4MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234490ANALOG HYBRID MICRO MINI ABUT.Sin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234506ANALOG HYBRID 4.5IHSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234513ANALOG HYBRID 3.5IHSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234520ANALOG HYBRID 3.0IHSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234537ANALOG HYBRID HI Ø4.5MMSin Sistema de Implante Nacional S/ANDP2026-10-29
07899995234544ANALOG HYBRID HI Ø3.8MMSin Sistema de Implante Nacional S/ANDP2026-10-29