FDA.report

FirstPlug Alpha 2.0

Primary DI
00860005367245
Brand
FirstPlug Alpha 2.0
Company
35newtons L.L.C.
Model
A000020-060
Catalog number
A20-060
Device description
FirstPlug Alpha 2.0 Screw Channel Barrier 300 cm
Published
2025-02-01
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

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860005367245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005367245008600053672458600053672450860005367245

GMDN Terms

TermDefinition
Antimicrobial dental prosthesis/implant plugA small device intended to remain in place long-term (>30 days) and designed to plug the hole in a screw-retained crown or dental prosthesis abutment to prevent the penetration of cement, filling material or bacteria into the free space above the screw. It is in the form of an elongated cone typically made of polymer materials, and includes an antimicrobial agent (e.g., silver). This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
122626175
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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 DIBrandModelCatalogPublished
00860005367252FirstPlug P000017-005P000017-0052025-01-28
00860005367207FirstPlugP000017-001P000017-0012024-07-02
00860005367221FirstPlugP000017-003P000017-0032024-07-02
00860005367238FirstPlugP000017-004P000017-0042024-07-02

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