FDA.report

3M™ ESPE™ MDI Max with O-Ball Head and Collar

Primary DI
30605861053953
Brand
3M™ ESPE™ MDI Max with O-Ball Head and Collar
Company
3M COMPANY
Model
2.4 mm x 15 mm
Catalog number
MOB-15
Device description
3M™ ESPE™ MDI Mini Dental Implant O-Ball Prosthetic Head MOB-15, Collared MAX 2.4 x 15mm
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30605861053953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3060586105395330605861053953

GMDN Terms

TermDefinition
Screw endosteal dental implant, one-pieceA 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.

Device Sizes

TypeValueUnit
Length15Millimeter
Width2.4Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)634-22493mespe@3m.com

Regulatory Flags

DUNS number
830016148
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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