FDA.report

Flexi-Overdenture

Primary DI
00766054001850
Brand
Flexi-Overdenture
Company
ESSENTIAL DENTAL SYSTEMS, INC.
Model
290-02
Catalog number
290-02
Device description
Flexi-Overdenture Wrench
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
false

Related Records

Contact Domains

Product Codes

CodeName
EJBHANDLE, INSTRUMENT, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00766054001850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00766054001850007660540018507660540018500766054001850

GMDN Terms

TermDefinition
Pin/post dental drill bitA shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device.

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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00766054002949BIOSEAL1640-001640-002024-10-31
00766054002970BIOSEAL1640-151640-152024-10-31
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00766054002918Bio-LCB910-03910-032022-10-28
00766054002925Bio-LCB910-50910-502022-10-28
00766054002932Bio-LCB910-01910-012022-10-28
00766054000617Tango-Endo5425-005425-002020-07-17
00766054000624Tango-Endo5421-005421-002020-07-17
00766054000631Tango-Endo5421-025421-022020-07-17
00766054000648Tango-Endo5425-025425-022020-07-17
00766054000655Tango-Endo5421-045421-042020-07-17
00766054000662Tango-Endo5425-045425-042020-07-17
00766054000679Tango-Endo5425-405425-402020-07-17
00766054000686Tango-Endo5425-505425-502020-07-17
00766054000693Tango-Endo5300-005300-002020-07-17
00766054000709Tango-Endo5400-015400-012020-07-17
00766054000716SafeSiders5021-GLP5021-GLP2020-07-17

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