FDA.reportPublic FDA data

ABIDING SOLO IMPRESSION CAP

Primary DI
08800020802804
Brand
ABIDING SOLO IMPRESSION CAP
Company
SNUCONE Co.,LTD.
Model
ASICM-45-5
Published
2026-05-26
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

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
08800020802804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800020802804088000208028048800020802804

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment impression capA small device intended to be placed intraorally on the abutment head of a dental implant during a dental impression to facilitate removal of the impression material once it has hardened, and to reproduce the intraoral position and orientation of the abutment/implant in a dental laboratory working model, for the fabrication of a final dental prosthesis (e.g., denture). 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800020807151SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-4810-72026-09-22
08800020807168SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-4820-72026-09-22
08800020807175SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-4830-72026-09-22
08800020807182SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-4840-72026-09-22
08800020807199SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6010-52026-09-22
08800020807205SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6020-52026-09-22
08800020807212SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6030-52026-09-22
08800020807229SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6040-52026-09-22
08800020807236SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6010-72026-09-22
08800020807243SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6020-72026-09-22
08800020807250SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6030-72026-09-22
08800020807267SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6040-72026-09-22
08800020807311SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-4810-72026-09-22
08800020807328SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-4820-72026-09-22
08800020807335SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-4830-72026-09-22
08800020807342SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-4840-72026-09-22
08800020807359SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6010-52026-09-22
08800020807366SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6020-52026-09-22
08800020807373SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6030-52026-09-22
08800020807380SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6040-52026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640149886726TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886733TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886757TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886764TRITRI Dental Implants Int. AGNDP2026-10-06
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052401N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052418N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052425N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052432N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052517N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052524N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052531N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052548N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052555N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052630N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052647N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052654N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052661N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052678N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052685N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052692N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052708N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052715N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052722N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052739N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052746N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052753N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052760N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052777N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053224N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01