FDA.reportPublic FDA data

RP cover screw

Primary DI
07290120488953
Brand
RP cover screw
Company
SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD
Model
6.0 x 3.5mm
Catalog number
CS-6035
Published
2026-05-18
Public version status
New
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
K242217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242217000Surcam Dental Implant SystemSurcam Medical Devices and Developments, Ltd.2025-01-29DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290120488953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290120488953072901204889537290120488953

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
514799902
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290120485181IH 25° Smooth Abutmenttotal height 13.5mmASM13252026-05-18
07290120485655RP Abutment Screw2.2 x 7.1mmSC3001322026-05-18
07290120486201IH Multi-Unit Screw2.0 x 6.45mmSCA25652026-05-18
07290120486508IH Abutment Screw2.1 x 8mmSCP25802026-05-18
07290120486607Screw for multi-unit titanium sleeve2.28 x 4.5mmSMU-40232026-05-18
07290120486652Screw for multi-unit titanium sleeve longer version2.2 x 5mmSMU-50222026-05-18
07290120486850NP cover screw6.0 x 3.1mmCS-3000292026-05-18
07290120489004IH cover screw4.0 x 3.5mmCSC-10002026-05-18
07290120480148IH titanium sleeve for multi-unit6.0 x 12.0 mmMP3000762026-05-14
07290120481275IH titanium sleeve for multi-unit5.0 x 4.1 mmCMU3001342026-05-14
07290120481695healing cap NP diameter 3.6mm 8.30mmHC3000312026-05-14
07290120481749healing cap NP diameter 3.6mm 10.30mmHC3000322026-05-14
07290120481794healing cap NP diameter 3.6mm 12.30mmHC3000332026-05-14
07290120481848healing cap RP diameter 3.6mm 8.30mmHC3000342026-05-14
07290120481893healing cap RP diameter 3.6mm 10.30mmHC3000352026-05-14
07290120481947healing cap RP diameter 3.6mm 12.30mmHC3000362026-05-14
07290120481992healing cap RP diameter 5.0mm 8.30mmHC3001052026-05-14
07290120482043healing cap RP diameter 5.0mm 10.30mmHC3001062026-05-14
07290120482098healing cap RP diameter 5.0mm 12.30mmHC3001072026-05-14
07290120482142healing cap NP diameter 5.0mm 8.30mmHC3001082026-05-14

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