FDA.reportPublic FDA data

Spirapost-Parallel Posts

Primary DI
D0338881011
Brand
Spirapost-Parallel Posts
Company
DMG AMERICA, LLC
Model
888101
Catalog number
888101
Device description
Spirapost PFS Parallel Refill Package (10 Parallel Posts, 1 #5 Gates Glidden)
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELRPost, Root Canal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELRPost, Root CanalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060075000FIBER-METAL POSTForemost Dental, LLC2006-03-30ELR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0338881011PrimaryHIBCC0
D0338881010Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Root canal post kitA collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
2018945505gvazquez@dmg-america.com

Regulatory Flags#

DUNS number
106792427
Device count
10
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00325047000005DMG2206002206002025-11-06
D0337884101Kolorz Prophylaxis Paste7884102025-06-04
D0337884111Kolorz Prophylaxis Paste7884112025-06-04
D0337884100Kolorz Prophylaxis Paste7884102025-06-04
D0337884110Kolorz Prophylaxis Paste7884112025-06-04
D0331430200TEMP TABS1430202025-04-18
D0331430330TEMP TABS1430332025-04-18
D033003619011ZenithDental61901003-619012016-09-23
D033003610961Zekrya Gingival Protector Kit003-61096003-610962022-12-12
D033003610971Zekrya Small Arc003-61097003-610972022-12-12
D033003610981Zekrya Large Arc003-61098003-610982022-12-12
D0337884011Kolorz Prophylaxis Paste7884017884012022-12-12
D0337884021Kolorz Prophylaxis Paste7884027884022022-12-12
D0337884031Kolorz Prophylaxis Paste7884037884032022-12-12
D0337884041Kolorz Prophylaxis Paste7884047884042022-12-12
D0337884061Kolorz Prophylaxis Paste7884067884062022-12-12
D0337884071Kolorz Prophylaxis Paste7884077884072022-12-12
D0337884081Kolorz Prophylaxis Paste7884087884082022-12-12
D0337884091Kolorz Prophylaxis Paste7884097884092022-12-12
D0337884151Kolorz Prophylaxis Paste7884157884152022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059388441167Prosthetic Over Post # 0OVERFIBERS SRLELR2025-03-12
08059388441174Prosthetic Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441181Prosthetic Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441198Prosthetic Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388441204Prosthetic Over Post # 4OVERFIBERS SRLELR2025-03-12
08059388441211Over Post+ # 0OVERFIBERS SRLELR2025-03-12
08059388441228Over Post+ # 1OVERFIBERS SRLELR2025-03-12
08059388441235Over Post+ # 2OVERFIBERS SRLELR2025-03-12
08059388441242Over Post+ # 3OVERFIBERS SRLELR2025-03-12
08059388441259Over Post+ # 4OVERFIBERS SRLELR2025-03-12
08059388441365Endodontic Over Post # 0OVERFIBERS SRLELR2025-03-12
08059388441372Endodontic Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441389Endodontic Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441396Endodontic Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388441402Endodontic Over Post # 4OVERFIBERS SRLELR2025-03-12
08059388441518Duo Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441525Duo Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441556Polygon Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441563Polygon Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441570Polygon Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388441617Hi-Rem Prosthetic Post # 0OVERFIBERS SRLELR2025-03-12
08059388441624Hi-Rem Prosthetic Post # 1OVERFIBERS SRLELR2025-03-12
08059388441631Hi-Rem Prosthetic Post # 2OVERFIBERS SRLELR2025-03-12
08059388441648Hi-Rem Prosthetic Post # 3OVERFIBERS SRLELR2025-03-12
08059388441655Hi-Rem+ # 0OVERFIBERS SRLELR2025-03-12
08059388441662Hi-Rem+ # 1OVERFIBERS SRLELR2025-03-12
08059388441679Hi-Rem+ # 2OVERFIBERS SRLELR2025-03-12
08059388441686Hi-Rem+ # 3OVERFIBERS SRLELR2025-03-12
08059388441778Hi-Rem Endodontic Post # 1OVERFIBERS SRLELR2025-03-12
08059388441785Hi-Rem Endodontic Post # 2OVERFIBERS SRLELR2025-03-12