FDA.reportPublic FDA data

SPIDER SCREW

Primary DI
08057013140553
Brand
SPIDER SCREW
Company
H.D.C. SRL
Model
SCR-1508
Catalog number
SCR-1508
Device description
SPIDER Screw K1 SHORT NECK Ø1,5x8 mm
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K071851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071851000HDC STERILE SPIDER SCREWHdc S.R.L.2007-10-18DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057013140553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057013140553080570131405538057013140553

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic anchoring screwA small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
339583417
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057013140447SPIDER SCREWSCL-1308SCL-13082016-08-24
08057013140454SPIDER SCREWSCL-1310SCL-13102016-08-24
08057013140461SPIDER SCREWSCL-1506SCL-15062016-08-24
08057013140478SPIDER SCREWSCL-1508SCL-15082016-08-24
08057013140485SPIDER SCREWSCL-1510SCL-15102016-08-24
08057013140508SPIDER SCREWSCL-1906SCL-19062016-08-24
08057013140515SPIDER SCREWSCL-1907SCL-19072016-08-24
08057013140522SPIDER SCREWSCL-1909SCL-19092016-08-24
08057013140539SPIDER SCREWSCL-1911SCL-19112016-08-24
08057013140546SPIDER SCREWSCR-1506SCR-15062016-08-24
08057013140560SPIDER SCREWSCR-1510SCR-15102016-08-24
08057013140584SPIDER SCREWSCR-1906SCR-19062016-08-24
08057013140591SPIDER SCREWSCR-1907SCR-19072016-08-24
08057013140607SPIDER SCREWSCR-1909SCR-19092016-08-24
08057013140614SPIDER SCREWSCR-1911SCR-19112016-08-24
08057013140645SPIDER SCREWSLP-1506SLP-15062016-08-24
08057013140652SPIDER SCREWSLP-1508SLP-15082016-08-24
08057013140669SPIDER SCREWSLP-1510SLP-15102016-08-24
08057013140676SPIDER SCREWSSM-1506SSM-15062016-08-24
08057013140683SPIDER SCREWSSM-1508SSM-15082016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070202999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203088ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203095ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203101ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203118ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28