AccessGUDID - DEVICE: 3M™ ESPE™ MDI Max with an O-Ball Head (30605861054431)

GUDID

Device Identifier (DI) Information

Brand Name: 3M™ ESPE™ MDI Max with an O-Ball Head
Version or Model: 2.4 mm x 15 mm
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: S1815MOB
Company Name: 3M COMPANY

Primary DI Number: 30605861054431
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 830016148 *Terms of Use

Device Description: 3M™ ESPE™ MDI Mini Dental Implant O-Ball Prosthetic Head - 2.4 x 15mm - S1815MOB

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
55848	Screw endosteal dental implant, one-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 one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) 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 [?]
Premarket Submission Number Not Available/Not Released

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: 15 Millimeter
Width: 2.4 Millimeter

Device Record Status

Public Device Record Key: 8f82f1d4-46be-49e2-b221-062971e5f547
Public Version Date: April 30, 2021
Public Version Number: 3
DI Record Publish Date: October 23, 2015