FDA.reportPublic FDA data

BONE PROFILER SLEEVE

Primary DI
D7702752973
Brand
BONE PROFILER SLEEVE
Company
SWEDEN & MARTINA SPA
Model
GS-LC-50-L
Catalog number
GS-LC-50-L
Device description
BONE PROFILER SLEEVE 5.0, LONG
Published
2026-03-25
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
D7702752973PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
844.862.7846info.us@sweden-martina.com

Regulatory Flags#

DUNS number
433815198
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7702757503T-CONNECT FOR SINGLEA-TC-330A-TC-3302026-05-08
D7702757513T-CONNECT FOR SINGLEA-TC-330-ROTA-TC-330-ROT2026-05-08
D7702757523T-CONNECT FOR SINGLEA-TC-380A-TC-3802026-05-08
D7702757533T-CONNECT FOR SINGLEA-TC-380-ROTA-TC-380-ROT2026-05-08
D7702680193P.A.D. ABUTMENTA-PADE-AA330-453A-PADE-AA330-4532026-04-29
D7702680203P.A.D. ABUTMENTA-PADE-AA330-455A-PADE-AA330-4552026-04-29
D7702680253P.A.D. ABUTMENTA-PADE-AA380-453A-PADE-AA380-4532026-04-29
D7701508203TRANSGINGIVAL HEALING CAP H5MMA-TO-380-5A-TO-380-52026-04-09
D7701508213TRANSGINGIVAL HEALING CAP H7MMA-TO-380-7A-TO-380-72026-04-09
D7701508223TRANSGINGIVAL HEALING CAPA-TO-380-9A-TO-380-92026-04-09
D7700420293ANALOGUE FOR IMPLANT ANA-600ANA-6002026-04-03
D7700421003PRE-MADE REP. POST STRAIGHTMDPA-600-6PBMDPA-600-6PB2026-04-03
D7700421093OPEN TRAY TRANSFER FOR PRE-KOHTRAR-600 TRAR-600 2026-04-03
D7701272533SURGICAL KIT SHELTAP-PSHELTAP-P2026-03-27
D7702695873SURGICAL KIT GS-L-50-PGS-L-50-P2026-03-27
D7701350253SURGICAL KIT ECHOPLAN PROGS-PRO-S-PGS-PRO-S-P2026-03-25
D7701411583ABUTMENT TIT. D.12L-CAMT-38005-12-SWL-CAMT-38005-12-SW2026-03-25
D7701411593ABUTMENT TIT. D.12L-CAMT-42505-12-SWL-CAMT-42505-12-SW2026-03-25
D7701411603ABUTMENT TIT. D.12L-CAMT-50005-12-SWL-CAMT-50005-12-SW2026-03-25
D7701411883ABUTMENT TIT. D.12XA-CAMT-ABU-12-SWXA-CAMT-ABU-12-SW2026-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03