FDA.reportPublic FDA data

ROEKO Stay-put

Primary DI
E1655210010
Brand
ROEKO Stay-put
Company
Coltène/Whaledent GmbH + Co. KG
Model
521001
Catalog number
521001
Device description
ROEKO Stay-put non-impregnated size 1 (fine)
Published
2022-09-22
Public version status
Update
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
MVLCord, Retraction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVLCord, RetractionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041023000STAY-PUT IMPREGNATEDColtene/Whaledent GmbH & Co. KG2004-06-15MVL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E1655210010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction cord, non-medicatedA non-medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4973458050info.de@coltene.com

Regulatory Flags#

DUNS number
315494443
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E1654610480ROEKO Aspirator tips4610484610482016-08-23
E1654620120ROEKO Surgitip-micro4620124620122016-08-23
E1654620130ROEKO Surgitip-micro4620134620132016-08-23
E1654620250ROEKO Surgitip4620254620252016-08-23
E1654620260ROEKO Surgitip4620264620262016-08-23
E1654620480ROEKO Surgitip4620484620482016-08-23
E1654620490ROEKO Surgitip4620494620492016-08-23
E1654630000ROEKO Double adapter4630004630002016-08-23
E1654630110ROEKO Adapter4630114630112016-08-23
E1654630250ROEKO Adapter4630254630252016-08-23
E165600182800ROEKO Surgitip-endo60018280600182802016-08-23
E165600191450ROEKO SurgitipSAMPLE EN600191452016-08-23
14260614073576HyFlex EDM60041081600410812025-10-22
14260614073583HyFlex EDM60041082600410822025-10-22
14260614073590HyFlex EDM60041083600410832025-10-22
14260614073606HyFlex EDM60041084600410842025-10-22
14260614073613HyFlex EDM60041085600410852025-10-22
14260614073620HyFlex EDM60041086600410862025-10-22
14260614073637HyFlex EDM60041087600410872025-10-22
14260614073644HyFlex EDM60041088600410882025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J014660872140Retraxil blueKulzer GmbHMVL2026-04-21
J014660872150Retraxil blueKulzer GmbHMVL2026-04-21
J014661012760Retraxil blueKulzer GmbHMVL2026-04-21
J014661012770Retraxil blueKulzer GmbHMVL2026-04-21
J014661012780Retraxil blueKulzer GmbHMVL2026-04-21
00850079280274Sure CordHexa DentalMVL2026-03-04
00008579280274sure EndoHexa DentalMVL2026-01-22
00850079280182Sure EndoHexa DentalMVL2026-01-22
00850079280199Sure EndoHexa DentalMVL2026-01-22
00850079280205Sure endoHexa DentalMVL2026-01-22
00850079280212Sure EndoHexa DentalMVL2026-01-22
00850079280229Sure endoHexa DentalMVL2026-01-22
00850079280236Sure EndoHexa DentalMVL2026-01-22
00850079280243Sure EndoHexa DentalMVL2026-01-22
00850079280250Sure EndoHexa DentalMVL2026-01-22
00850079280267Sure EndoHexa DentalMVL2026-01-22
00850079280281SDure endoHexa DentalMVL2026-01-22
00850079280175Sure EndoHexa DentalMVL2026-01-21
10818207024968Traxodent Gel AlCl - Bulk Syringe KitVista DentalMVL2025-06-30
10818207024975Traxodent Gel AlCl - Sample PackVista DentalMVL2025-06-30
10818207024982Traxodent Gel AlCl - Value PackVista DentalMVL2025-06-30
10818207024999Traxodent Gel AlCl - Refill KitVista DentalMVL2025-06-30
10818207025002Traxodent Gel FS - Bulk Syringe KitVista DentalMVL2025-06-30
10818207025019Traxodent Gel FS - Value PackVista DentalMVL2025-06-30
10818207025026Traxodent Gel FS - Refill KitVista DentalMVL2025-06-30
00359883005665Tissue Goo™ Hemostatic Gel 4-PackDEN-MAT HOLDINGS, LLCMVL2025-03-18
00359883005672Tissue Goo™ Hemostatic Gel Big Shot Syringe KitDEN-MAT HOLDINGS, LLCMVL2025-03-18
00359883005634First String Advanced Braided Retraction Cord Non-Impregnated - SmallDEN-MAT HOLDINGS, LLCMVL2025-03-12
00359883005641First String Advanced Braided Retraction Cord Non-Impregnated - MediumDEN-MAT HOLDINGS, LLCMVL2025-03-12
00359883005658First String Advanced Braided Retraction Cord Non-Impregnated - LargeDEN-MAT HOLDINGS, LLCMVL2025-03-12