FDA.reportPublic FDA data

INTRAORAL SCANBODY

Primary DI
D7702750853
Brand
INTRAORAL SCANBODY
Company
SWEDEN & MARTINA SPA
Model
SB-INF
Catalog number
SB-INF
Device description
INTRAORAL SCANBODY FOR ARCH ALIGNMENT, LOWER JAW
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
false

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
D7702750853PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, intraoral-scanning, single-useAn intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use 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
false
Premarket exempt
true
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
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
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
D7701272533SURGICAL KIT SHELTAP-PSHELTAP-P2026-03-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08059224151588OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218205OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218335OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218700OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224218717OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
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08800131098264DenQ Sub Multi-unit Lab AnalogDenQ Co.,Ltd.NDP2026-08-25
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08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
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08800313235562Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
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