AccessGUDID - DEVICE: TitaniumBase EV ASA (XS) 2mm (05712821014108)

GUDID

Device Identifier (DI) Information

Brand Name: TitaniumBase EV ASA (XS) 2mm
Version or Model: 68012551
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 68012551
Company Name: Elos Medtech Pinol A/S

Primary DI Number: 05712821014108
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 306155953 *Terms of Use

Device Description: The TitaniumBase EV ASA is a two-piece abutment which is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The TitaniumBase EV ASA is available in an indexed variant for single unit restorations and a non-indexed variant for multi-unit restorations. The TitaniumBase EV ASA is available in different gingival heights. The TitaniumBase EV ASA has a chimney height of 7.5 mm which can be shortened as far as 3.5 mm at predefined grooves. TitaniumBase EV ASA size XS is limited to replacement of maxillary lateral incisors and mandibular incisors.

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?
44879	Dental implant suprastructure, permanent, preformed	A 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NHA	Abutment, Implant, Dental, Endosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242025	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ddf0efd3-980f-411a-9204-f8c64dab26a5
Public Version Date: December 20, 2024
Public Version Number: 1
DI Record Publish Date: December 12, 2024