FDA.reportPublic FDA data

COUPLE IMPRESSION COPING PICK-UP

Primary DI
08800020804709
Brand
COUPLE IMPRESSION COPING PICK-UP
Company
SNUCONE Co.,LTD.
Model
ACIPN-55L
Published
2023-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
08800020804709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800020804709088000208047098800020804709

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure kitA collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999snucone@naver.com

Regulatory Flags#

DUNS number
688806132
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800020802767ABIDING SOLO IMPRESSION CAPASICM-40-42026-05-26
08800020802774ABIDING SOLO IMPRESSION CAPASICM-40-52026-05-26
08800020802781ABIDING SOLO IMPRESSION CAPASICM-40-72026-05-26
08800020802798ABIDING SOLO IMPRESSION CAPASICM-45-42026-05-26
08800020802804ABIDING SOLO IMPRESSION CAPASICM-45-52026-05-26
08800020802811ABIDING SOLO IMPRESSION CAPASICM-45-72026-05-26
08800020802828ABIDING SOLO IMPRESSION CAPASIC-452026-05-26
08800020802835ABIDING SOLO IMPRESSION CAPASIC-552026-05-26
08800020802842ABIDING SOLO IMPRESSION CAPASIC-652026-05-26
08800020802859SOLO LAB ANALOGASLAM-40-42026-05-26
08800020802866SOLO LAB ANALOGASLAM-40-52026-05-26
08800020802873SOLO LAB ANALOGASLAM-40-72026-05-26
08800020802880SOLO LAB ANALOGASLAM-45-42026-05-26
08800020802897SOLO LAB ANALOGASLAM-45-52026-05-26
08800020802903SOLO LAB ANALOGASLAM-45-72026-05-26
08800020802910SOLO LAB ANALOGASLA-452026-05-26
08800020802927SOLO LAB ANALOGASLA-552026-05-26
08800020802934SOLO LAB ANALOGASLA-652026-05-26
08800020802996SOLO PLASTIC COPINGASPCSM-402026-05-26
08800020803009SOLO PLASTIC COPINGASPCSM-452026-05-26

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