AccessGUDID - DEVICE: OKTAGON BL NC Healing abutment Ø 5.0 mm (EDRS220331)

GUDID

Device Identifier (DI) Information

Brand Name: OKTAGON BL NC Healing abutment Ø 5.0 mm
Version or Model: 22033
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 22033
Company Name: Hager & Meisinger Gesellschaft mit beschränkter Haftung

Primary DI Number: EDRS220331
Issuing Agency: HIBCC
Commercial Distribution End Date: March 19, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 318034329 *Terms of Use

Device Description: BL NC Healing abutment Ø 5.0 mm for OKTAGON Dental Implant BL NC

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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 [?]
K143539	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: 3c83804d-513d-4381-8787-0a2f448250c1
Public Version Date: May 29, 2026
Public Version Number: 5
DI Record Publish Date: January 27, 2017