FDA.report

AccessPost Overdenture

Primary DI
00766054000587
Brand
AccessPost Overdenture
Company
ESSENTIAL DENTAL SYSTEMS, INC.
Model
550-01
Catalog number
550-01
Device description
AccessPost Overdenture EZ-Change Refill (Keepers-Caps-Bands)
Published
2020-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00766054000587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00766054000587007660540005877660540005870766054000587

GMDN Terms

TermDefinition
Denture clasp, polymer, preformedA prefabricated dental device made of polymer material intended to retain and stabilize a removable partial denture to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(201)487-9090udi@edsdental.com

Regulatory Flags

DUNS number
101147171
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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