FDA.reportPublic FDA data

Panthera Dental Milled Bar

Primary DI
07540204000046
Brand
Panthera Dental Milled Bar
Company
Panthera Dentaire Inc
Model
1
Device description
The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
Published
2024-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K173466000
K183580000
K192108000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173466000Panthera Dental Milled BarsPanthera Dental, Inc.2018-01-26NHA
K183580000Panthera Dental Milled BarsPanthera Dental, Inc.2019-06-20NHA
K192108000Panthera Dental Milled BarsPanthera Dental, Inc.2020-04-08NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540204000039PreviousGS10
07540204000046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540204000039075402040000397540204000039
07540204000046075402040000467540204000046

GMDN Terms#

Term, Definition table
TermDefinition
Bar dental precision attachmentA small shaft or splint typically made of austenitic alloys or alloys containing 75 percent or greater gold (Au) and metals of the platinum group, intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture. The device typically includes fixers (e.g., clasps, sleeves, or screws).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
855-233-0388info@pantheradental.com

Regulatory Flags#

DUNS number
203254607
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540204000299Panthera D-Guide Single sided12026-04-06
07540204000305Panthera D-Guide Double sided12026-04-06
07540204000275Panthera D-SAD Classic Duo12025-11-28
07540204000282Panthera D-SAD X3 Duo12025-11-28
07540204000022The Panthera Anti-Snoring X3 Device12018-05-10
07540204000091Angulated Screwdriver Unigrip 30mm340142025-01-09
07540204000107Angulated Screwdriver 0.050 30mm340152025-01-09
07540204000114Angulated Screwdriver 0.048 30mm340162025-01-09
07540204000121Angulated Screwdriver KCS 30mm340172025-01-09
07540204000138Angulated Screwdriver Unigrip 20mm340182025-01-09
07540204000145Angulated Screwdriver 0.050 20mm340192025-01-09
07540204000152Angulated Screwdriver 0.048 20mm340202025-01-09
07540204000169Angulated Screwdriver KCS 20mm340212025-01-09
07540204000053The Panthera Anti-Snoring Device12024-10-28
07540204000060Panthera D-SAD X312024-10-28
07540204000077Panthera Occlusal Appliance - Single12024-10-28
07540204000015The Panthera Anti-Snoring Device12016-09-23
07540204000039Panthera Dental Milled Bar12018-02-19

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Primary DI, Brand, Company table
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00842092122396Preat Implant ProstheticsPreat CorporationNHA2022-11-22
00842092125632PreatPreat CorporationNHA2022-10-24
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