AccessGUDID - DEVICE: JDEvolution Plus (08056591011415)

GUDID

Device Identifier (DI) Information

Brand Name: JDEvolution Plus
Version or Model: JDEvolution Plus PT Anodized Collar Ø 4.0 L 11.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PT40115:
Company Name: J DENTAL CARE SRL

Primary DI Number: 08056591011415
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428716597 *Terms of Use

Device Description: JDEvolution Plus PT Anodized Collar Ø 4.0 L 11.5

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?
55847	Dental implant system	A collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DZE	Implant, Endosseous, Root-Form

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233896	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 80e1398c-b3e0-43f6-ad40-65cf1d2059ad
Public Version Date: September 10, 2024
Public Version Number: 1
DI Record Publish Date: September 02, 2024