FDA.reportPublic FDA data

IH Healing Cap Extra Wide 6.3mm

Primary DI
07290117802489
Brand
IH Healing Cap Extra Wide 6.3mm
Company
R.D.J. TOV IMPLANT LTD
Model
3mm
Catalog number
VCXL3
Published
2025-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240837000TOV Dental Implant SystemRdj Tov Implant, Ltd.2024-08-15DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290117802489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290117802489072901178024897290117802489

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
600199501
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290117802915IH Straight Multi-Unit ScrewSCRWMUSCRWMU2025-02-26
07290117802922IH Angled Multi-Unit ScrewSCRWMUASCRWMUA2025-02-26
07290117802939Conical RP Straight and Angled Multi-Unit ScrewSCRHTRODSCRHTROD2025-02-26
07290117802946Conical NP Straight and Angled Multi-Unit ScrewSSFMUSSFMU2025-02-26
07290117802526IH Ball Attachment2mmAB22025-02-19
07290117802533IH Ball Attachment3mmAB32025-02-19
07290117802540IH Ball Attachment4mmAB42025-02-19
07290117802557IH Ball Attachment5mmAB52025-02-19
07290117802564IH Ball Attachment6mmAB62025-02-19
07290117802571IH Ball Attachment7mmAB72025-02-19
07290117802588Conical NP Ball Attachment1mmCAB12025-02-19
07290117802595Conical NP Ball Attachment2mmCAB22025-02-19
07290117802601Conical NP Ball Attachment3mmCAB32025-02-19
07290117802618Conical NP Ball Attachment4mmCAB42025-02-19
07290117802625Conical NP Ball Attachment5mmCAB52025-02-19
07290117802632Conical NP Ball Attachment6mmCAB62025-02-19
07290117802649Conical RP Ball Attachment1mmCAB1 RP2025-02-19
07290117802656Conical RP Ball Attachment2mmCAB2 RP2025-02-19
07290117802663Conical RP Ball Attachment3mmCAB3 RP2025-02-19
07290117802670Conical RP Ball Attachment4mmCAB4 RP2025-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNHA2026-07-13
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092184394PreatPreat CorporationNHA2025-07-24
D762MUA030500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA031000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA032000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA033000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA034000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345HCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345TBM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345VCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA035000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA040500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA041000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA042000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA043000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA044000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA045000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA050500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA051000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA052000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA053000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA054000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA055000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS0300010Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS1635230Implant-OneImplant Logistics, Inc.NHA2024-12-06