FDA.reportPublic FDA data

Plastic Impression Coping

Primary DI
08806388230471
Brand
Plastic Impression Coping
Company
Megagen Implant Co. Ltd
Model
PIC
Catalog number
PIC
Device description
Common L=9
Published
2015-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150537000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150537000MiNi Internal Implant SystemMegagen Implant Co., Ltd.2015-07-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388230471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388230471088063882304718806388230471

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
687388178
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388221066AnyOne Internal FixtureIF5008IF5008C2015-06-25
08806388221073AnyOne Internal FixtureIF5008IF50082015-06-25
08806388221080AnyOne Internal FixtureIF5010IF5010C2015-06-29
08806388221097AnyOne Internal FixtureIF5010IF50102015-06-25
08806388221103AnyOne Internal FixtureIF5011IF5011C2015-06-25
08806388221110AnyOne Internal FixtureIF5011IF50112015-06-25
08806388221127AnyOne Internal FixtureIF5013IF5013C2015-06-25
08806388221134AnyOne Internal FixtureIF5013IF50132015-06-25
08806388221141AnyOne Internal FixtureIF5015IF5015C2015-06-25
08806388221158AnyOne Internal FixtureIF5015IF50152015-06-25
08806388221165AnyOne Internal FixtureIF5507DIF5507DC2015-06-25
08806388221172AnyOne Internal FixtureIF5508DIF5508DC2015-06-25
08806388221189AnyOne Internal FixtureIF5510DIF5510DC2015-06-25
08806388221196AnyOne Internal FixtureIF5511DIF5511DC2015-06-25
08806388221202AnyOne Internal FixtureIF5513DIF5513DC2015-06-25
08806388221219AnyOne Internal FixtureIF5515DIF5515DC2015-06-25
08806388221226AnyOne Internal FixtureIF6007IF6007C2015-06-25
08806388221233AnyOne Internal FixtureIF6007IF60072015-06-25
08806388221240AnyOne Internal FixtureIF6007SIF6007SC2015-06-25
08806388221257AnyOne Internal FixtureIF6007SIF6007S2015-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
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