FDA.reportPublic FDA data

INTRAORAL SCANBODY

Primary DI
D7701814873
Brand
INTRAORAL SCANBODY
Company
SWEDEN & MARTINA SPA
Model
PADR-INT-CAMTRA-L
Catalog number
PADR-INT-CAMTRA-L
Device description
INTRAORAL SCANBODY FOR RED. PAD
Published
2022-03-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
D7701814873PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
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06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
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08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
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