FDA.report

EH

Primary DI
00816795020686
Brand
EH
Company
AURIDENT INC
Model
0.3ozt
Device description
Dental alloy restorations
Published
2017-03-06
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
EJTAlloy, Gold-Based Noble Metal

Product Code Classifications

CodeDeviceSpecialtyClass
EJTAlloy, Gold-Based Noble MetalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816795020686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816795020686008167950206868167950206860816795020686

GMDN Terms

TermDefinition
In-exsufflatorA portable, pneumatic, device that, through a rapid shift in pressure via a face mask, produces a high expiratory flow rate from the lungs, simulating a cough. This technique is referred to as EWNP (exsufflation with negative pressure) or mechanical insufflation-exsufflation. This device is suitable for any patient with an ineffective cough due to, e.g., muscular disorders or paralysis and would typically be used to clear retained broncho-pulmonary secretions, reducing the risk of respiratory complications.

Sterilization Methods

Method

Regulatory Flags

DUNS number
030580955
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00816795025421Delta Zirconia High Translucent DiscD812C3T2017-03-22
00816795025643Delta Zirconia High Translucent DiscD818D4T2017-03-23
08816795025445Delta Zirconia Multilayered Translucent DiscD812A1MUL/T2017-03-23
00816795024059Delta ZirconiaD810A0G2016-09-15
00816795024080Delta Zirconia TranslucentD810A1T2016-09-19
00816795024097Delta Zirconia TranslucentD810A2T2016-09-19
00816795024103Delta Zirconia TranslucentD810A3T2016-09-19
00816795024110Delta Zirconia TranslucentD810A3.5T2016-09-19
00816795024127Delta Zirconia TranslucentD810B2T2016-09-19
00816795024134Delta Zirconia TranslucentD810B3T2016-09-19
00816795024141Delta Zirconia TranslucentD810C2T2016-09-19
00816795024158Delta Zirconia TranslucentD810C3T2016-09-19
00816795024165Delta Zirconia TranslucentD810D2T2016-09-19
00816795024172Delta Zirconia D812A0G2016-09-19
00816795024196Delta Zirconia TranslucentD812A0TG2016-09-19
00816795024202Delta Zirconia TranslucentD812A1T2016-09-19
00816795024219Delta Zirconia TranslucentD812A2T2016-09-19
00816795024226Delta Zirconia TranslucentD812A3T2016-09-19
00816795024233Delta Zirconia TranslucentD812A3.5T2016-09-19

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97640173081862Dentalor 60Cendres+Métaux SAEJT2024-07-01
97640173082036Solaro 4Cendres+Métaux SAEJT2024-07-01
97640173082043Solaro 4Cendres+Métaux SAEJT2024-07-01
97640173082050Solaro 4Cendres+Métaux SAEJT2024-07-01
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