FDA.report

NA

Primary DI
EGEB82800
Brand
NA
Company
Gebdi Dental-Products GmbH
Model
82800
Device description
Preformed Bite Rims, red ( hard ), 100pc.
Published
2017-08-04
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
EGDWAX, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EGEB82800PrimaryHIBCC0

GMDN Terms

TermDefinition
Denture clasp, metal, custom-madeA dental device made of metal, typically in wire form, intended to retain and stabilize a removable partial denture to stationary teeth. It is manufactured to meet the specifications of an individual patient.

Sterilization Methods

Method

Regulatory Flags

DUNS number
342656675
Device count
1
DM exempt
true
Premarket exempt
true
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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