FDA.reportPublic FDA data

ROSEN SCREW

Primary DI
07290109747484
Brand
ROSEN SCREW
Company
BHI IMPLANTS LTD
Model
1
Catalog number
RS-SCREW1.4L
Device description
50 X Rosen Screw 1.4 Long
Published
2024-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K103280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103280000BHDENTAL IMPLANT SYSTEMBhdental, Ltd.2011-02-24NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109747484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109747484072901097474847290109747484

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1818-903-6736Rosenscrew@gmail.com

Regulatory Flags#

DUNS number
600330916
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109747941Parallel Pin 1GIH-20002026-04-05
07290109747958Parallel Pin 1GIH-20012026-04-05
07290109747965Hand Hex Drive1GIH-HD2M2026-04-05
07290109747972Hand Hex Drive1GIH-HD2L2026-04-05
07290109747989Motor Mount1GIH-MK2L2026-04-05
07290109747996Motor Mount1GIH-MK2S2026-04-05
07290109748016Hand Hex Drive1GIH-HD1L2026-04-05
07290109748023Hand Hex Drive1GIH-HD1S2026-04-05
07290109748030Motor Mount1GIH-1MKL2026-04-05
07290109748047Motor Mount1GIH-1MKS2026-04-05
07290109747934Bhi Implants1BH-NMUSS2026-01-20
07290109747781OsseoPress®1RS-OPD2252026-01-08
07290109747798OsseoPress®1RS-OPD2502026-01-08
07290109747804OsseoPress®1RS-OPD2752026-01-08
07290109747811OsseoPress®1RS-OPD3002026-01-08
07290109747828OsseoPress®1RS-OPD3252026-01-08
07290109747835OsseoPress®1RS-OPD3502026-01-08
07290109747842OsseoPress®1RS-OPD3752026-01-08
07290109747859OsseoPress®1RS-OPD4002026-01-08
07290109747866OsseoPress®1RS-OPD4252026-01-08

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