FDA.reportPublic FDA data

INSTRUMENTS TRAY FOR

Primary DI
D7702752883
Brand
INSTRUMENTS TRAY FOR
Company
SWEDEN & MARTINA SPA
Model
SB-TRAY-INT
Catalog number
SB-TRAY-INT
Device description
INSTRUMENTS TRAY FOR SCANBODY FOR ARCH ALIGNMENT
Published
2026-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7702752883PrimaryHIBCC0

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7702764233TRANSGINGIVAL HEALING CAP H3MMA-TMGA-380-3A-TMGA-380-32026-10-07
D7702764243TRANSGINGIVAL HEALING CAP H5MMA-TMGA-380-5A-TMGA-380-52026-10-07
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
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

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