FDA.reportPublic FDA data

Saturn (Prime)

Primary DI
07290112781215
Brand
Saturn (Prime)
Company
CORTEX - DENTAL IMPLANTS INDUSTRIES LTD
Model
BST-1038
Catalog number
BST-1038
Device description
Saturn Dental Implant 3.8mm 10mm L Prime
Published
2026-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

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
K131258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131258000SATURN DENTAL IMPLANTCortex Dental Implants Industries , Ltd.2014-03-17DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290112781212PackageGS110In Commercial Distribution
07290112781215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011278121217290112781212
07290112781215072901127812157290112781215

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-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 one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature00

Regulatory Flags#

DUNS number
532376956
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290112780010Magix (Prime)BCDL-0833BCDL-08332026-07-12
07290112780522Dynamix Hex (Prime)BCSD-1050BCSD-10502026-07-12
07290112780645Dynamix Hex (Prime)BCSD-1633BCSD-16332026-07-12
07290112780652Dynamix Hex (Prime)BCSD-1638BCSD-16382026-07-12
07290112781222Saturn (Prime)BST-1042BST-10422026-07-12
07290112781246Saturn (Prime)BST-1142BST-11422026-07-12
07290112781260Saturn (Prime)BST-1342BST-13422026-07-12
07290112781284Saturn (Prime)BST-1642BST-16422026-07-12
07290112781710Dynamix Hex (Premium)PCSD-1038PCSD-10382026-07-12
07290112781727Dynamix Hex (Premium)PCSD-1042PCSD-10422026-07-12
07290114710411Healing CapCO-7103CO-71032026-07-12
07290114710565AbutmentsCO-8015CO-80152026-07-12
07290114712156Abutments-AnalogMPN-8040DMPN-8040D2026-07-12
07290114712613Titanium-basesMPN-TBH1MPN-TBH12026-07-12
07290116660677Surgical DrillsCK-GS11CK-GS112026-07-12
07290116660882Surgical ToolsCT-0254CT-02542026-07-12
07290116660899Surgical ToolsCT-0260CT-02602026-07-12
07290116660981Surgical ToolsCT-0801CT-08012026-07-12
07290116661216Surgical ToolsCT-S215CT-S2152026-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230367ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230374ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230381ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230398ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26