FDA.report

AccessPost Overdenture

Primary DI
00766054000600
Brand
AccessPost Overdenture
Company
ESSENTIAL DENTAL SYSTEMS, INC.
Model
550-03
Catalog number
550-03
Device description
AccessPost Overdenture EZ-Change 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
true

Related Records

Contact Domains

Product Codes

CodeName
EJBHANDLE, INSTRUMENT, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00766054000600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00766054000600007660540006007660540006000766054000600

GMDN Terms

TermDefinition
Root canal post, preformedA prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use 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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00766054003007Turbo-CR1100-1001100-1002025-04-04
00766054002949BIOSEAL1640-001640-002024-10-31
00766054002970BIOSEAL1640-151640-152024-10-31
00766054002901Bio-LCB910-02910-022022-10-28
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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00371347017748Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00883205032164Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-21
00883205032157Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-19
08806343925183ever KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925213TAPER KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925220GUIDE KITShinhung MST Co., Ltd.EJB2025-07-28
08057639710567Specialist OrganizerMC BIO SRLEJB2025-06-23
08057639710574Tip with Indexable StopMC BIO SRLEJB2025-06-23
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08057639710604Long Tip SPMC BIO SRLEJB2025-06-23
08057639710628GBR MODULAR SETMC BIO SRLEJB2025-06-23
08057639712066Handle - Straight MDFMC BIO SRLEJB2025-06-23
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08057639712097Handle - Asym. - ErgalMC BIO SRLEJB2025-06-23
08057639712103Handle - Asym. - SP (TiN)MC BIO SRLEJB2025-06-23
08057639712110Handle - Asym. - TitaniumMC BIO SRLEJB2025-06-23