FDA.reportPublic FDA data

BLT OS Impression Coping

Primary DI
08809890906483
Brand
BLT OS Impression Coping
Company
EBI Inc.
Model
ONOICTR
Published
2024-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809890906483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809890906483088098909064838809890906483

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
689515003
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809823979157Immediate Placement DeviceIPIP2026-02-23
08809468050631Precision II ImplantIRAS41102025-10-02
08809468050648Precision II ImplantIRAS41122025-10-02
08809468050877Precision II ImplantIRSS33082025-10-02
08809468051355Precision II ImplantIWSS48082025-10-02
08809475971714Healing AbutmentSHAW7022025-10-02
08809823986223Abutment RemoverABR2025-10-02
08809823990749Double Hex Driver-T/WDBHDTS2025-10-02
08809476186407BLT OS Analog OBLHLAR2024-12-12
08809486111062BLT OS Abutment Screw ONOASR2024-12-12
08809475970410CCM UCLA Abutment (for Precision) [OCT]EICUC2016-03-29
08809475970427CCM UCLA Abutment (for Precision) [Non-Octa]EICUB2016-03-29
08809475970434CCM UCLA Abutment (for BESTic) [OCT]EBCUC2016-03-09
08809475970441CCM UCLA Abutment (for BESTic) [Non-Octa]EBCUB2016-03-09
08809475970670Precision Gold UCLA AbutmentEIGUC2016-03-02
08809475971684BESTic Healing Abutment SHAR5022017-11-22
08809475971790BESTic Healing Abutment BHAR4242016-03-02
08809475971806BESTic Healing Abutment BHAR4322016-03-02
08809475971868BESTic Healing Abutment BHAR5222016-03-02
08809475971875BESTic Healing Abutment BHAR5232016-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03