FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919833017
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5027276U0
Device description
K0386 DEAN KOIS IMPLANT SYS 1P
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00887919833017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919833017008879198330178879198330170887919833017

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

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919956815LARGE BONE BLADESSAW6944TSAW6944T2026-10-27
00887919956846LARGE BONE BLADESSAW6945TSAW6945T2026-10-27
00887919956877LARGE BONE BLADESSAW6946TSAW6946T2026-10-27
00887919956969LARGE BONE BLADESSAW6949TSAW6949T2026-10-27
00887919956990LARGE BONE BLADESSAW6950TSAW6950T2026-10-27
00887919957027LARGE BONE BLADESSAW6951TSAW6951T2026-10-27
00887919956907LARGE BONE BLADESSAW6947TSAW6947T2026-10-26
00887919956938LARGE BONE BLADESSAW6948TSAW6948T2026-10-26
08404535025309Brasseler USA5032037U05032037U02026-04-29
00887919673880Brasseler USA5022563U05022563U02023-01-25
00887919676218Brasseler USA5022790U05022790U02023-01-25
00887919676232Brasseler USA5022792U05022792U02023-01-25
00887919676249Brasseler USA5022793U05022793U02023-01-25
00887919810926Brasseler USA5026807U05026807U02023-01-25
08404535020779Brasseler USA5031841U05031841U02026-10-20
08404535020809Brasseler USA5031842U05031842U02026-10-20
08404535037654Brasseler USA5032402U05032402U02026-10-20
08404535037685Brasseler USA5032403U05032403U02026-10-20
08404535036985Brasseler USA5032405U05032405U02026-10-01
00887919581703DENTFLEX FIBER POST5013917L05013917L02026-09-28

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