FDA.report

NA

Primary DI
EGEB241131
Brand
NA
Company
Gebdi Dental-Products GmbH
Model
24113
Device description
TRIBOS 501 Kunststoffzaehne VO37-OK-C4
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ELMDenture, plastic, teeth

Product Code Classifications

CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EGEB241131PrimaryHIBCC0

GMDN Terms

TermDefinition
Partial dentureA custom-made, removeable, artificial replacement for one or more, but not all, teeth in the lower or upper jaw (mandible or maxilla) in a partially edentulous patient. It typically includes clasps of metal or plastic that clip onto remaining teeth for retention and stabilization. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. Also known as a removable partial denture (RPD).

Sterilization Methods

Method

Contacts

PhoneEmail
+497733941016info@gebdi-dental.com

Regulatory Flags

DUNS number
342656675
Device count
1
DM exempt
true
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
EGEB200011NA200012016-10-25
EGEB200021NA200022016-10-25
EGEB200031NA200032016-10-25
EGEB200041NA200042016-10-25
EGEB200051NA200052016-10-25
EGEB200061NA200062016-10-25
EGEB200071NA200072016-10-25
EGEB200081NA200082016-10-25
EGEB200091NA200092016-10-25
EGEB200101NA200102016-10-25
EGEB200111NA200112016-10-25
EGEB200121NA200122016-10-25
EGEB200131NA200132016-10-25
EGEB200141NA200142016-10-25
EGEB200151NA200152016-10-25
EGEB200161NA200162016-10-25
EGEB201011NA201012016-10-25
EGEB201021NA201022016-10-25
EGEB201031NA201032016-10-25
EGEB201041NA201042016-10-25

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