AccessGUDID - DEVICE: JDEvolution Plus (08055510176785)

GUDID

Device Identifier (DI) Information

Brand Name: JDEvolution Plus
Version or Model: JDEvolution Plus L Ø 4.0 L 26
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA40260:
Company Name: J DENTAL CARE SRL

Primary DI Number: 08055510176785
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428716597 *Terms of Use

Device Description: JDEvolution Plus L Ø 4.0 L 26

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 [?]
K251148	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
Length: 26 Millimeter

Device Record Status

Public Device Record Key: 55a7d7e0-9eb0-4620-93bb-4b418ee4e311
Public Version Date: December 01, 2025
Public Version Number: 1
DI Record Publish Date: November 21, 2025