FDA.reportPublic FDA data

SURGICAL KIT

Primary DI
D7701272533
Brand
SURGICAL KIT
Company
SWEDEN & MARTINA SPA
Model
SHELTAP-P
Catalog number
SHELTAP-P
Device description
SURGICAL KIT FOR SHELTA IMPLANT SYSTEM, FOR EXHIBITIONSURGICAL KIT FOR SHELTA IMPLANT SYSTEM, FOR EXHIBITIONPRAMA GS5.0, FOR EXHIBITION
Published
2026-03-27
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
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222640000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222640000Sweden & Martina Surgical TraysSweden & Martina S.P.A.2023-05-26KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7701272533PrimaryHIBCC0

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
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7702682153RIGHT ANGLE SCREWDRIVER FORYV-DR2-N-CA-CYV-DR2-N-CA-C2026-07-27
D7702698973DRILLCVV-F10CVV-F102026-07-27
D7702698983DRILLCVV-F14CVV-F142026-07-27
D7702750843INTRAORAL SCANBODYSB-SUPSB-SUP2026-07-27
D7702750853INTRAORAL SCANBODYSB-INFSB-INF2026-07-27
D7702752883INSTRUMENTS TRAY FORSB-TRAY-INTSB-TRAY-INT2026-07-27
D7702752893SURGICAL KITZSB-INTZSB-INT2026-07-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166521628X-PACEXPANDING INNOVATIONS, INC.KCT2026-07-30
00850001720830X-PACEXPANDING INNOVATIONS, INC.KCT2026-07-30
D7702752883INSTRUMENTS TRAY FORSWEDEN & MARTINA SPAKCT2026-07-27
D7702752893SURGICAL KITSWEDEN & MARTINA SPAKCT2026-07-27
10886705032266NAMedos International SàrlKCT2026-07-22
00190776400484MillenniumAvalign Technologies, Inc.KCT2026-07-21
00385640093323INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00385640093484INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00385640093491INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00385640093507INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00385640093514INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00763000830076Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.KCT2026-07-17
00653159014208CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014215CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014222CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014239CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014246CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014253CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014260CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014277CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014284CASE MEDICALCase Medical Inc.KCT2026-06-08
07630031779656Straumann Modular CassetteInstitut Straumann AGKCT2026-06-03
00810157315229Basic Surgical KitParagon Implant Mfg., LLCKCT2026-06-02
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
07640166769521Z5m(t)-neo InsertZ-Systems AGKCT2026-05-17
07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17
07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13