FDA.reportPublic FDA data

PRAMA WHITE IMPLANT ZIRTI

Primary DI
D7701340373
Brand
PRAMA WHITE IMPLANT ZIRTI
Company
SWEDEN & MARTINA SPA
Model
LAW-ZT-380-060
Catalog number
LAW-ZT-380-060
Device description
PRAMA WHITE IMPLANT ZIRTI D. 3.80 H. 6 MM
Published
2022-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180365000PRAMA White Implant SystemsSweden & Martina S.P.A.2019-07-08DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7701340373PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
433815198
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
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
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08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
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08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
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08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203347ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203354ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203361ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203378ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203385ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203392ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203408ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
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