AccessGUDID - DEVICE: Straumann® BLC and TLC Implants (07630031766700)

GUDID

Device Identifier (DI) Information

Brand Name: Straumann® BLC and TLC Implants
Version or Model: SLActive Roxolid TL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 035.7110S
Company Name: Institut Straumann AG

Primary DI Number: 07630031766700
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483599259 *Terms of Use

Device Description: TLC SP Implant, Ø 3.3mm RT, SLActive® 10mm, Roxolid®

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55849	Screw endosteal dental implant, two-piece	A 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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DZE	IMPLANT, ENDOSSEOUS, ROOT-FORM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230108	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 3.3 Millimeter
Length: 10 Millimeter

Device Record Status

Public Device Record Key: a3367acd-9f7b-425a-b597-2a7a6709d2af
Public Version Date: November 13, 2023
Public Version Number: 1
DI Record Publish Date: November 04, 2023