FDA.reportPublic FDA data

Re-Cord™ Knitted Retraction Cord #2

Primary DI
07540172009959
Brand
Re-Cord™ Knitted Retraction Cord #2
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
649105
Catalog number
649105
Device description
Gingival retraction cord, non-medicated
Published
2018-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JESFLOSS, DENTAL
MVLCORD, RETRACTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JESFloss, DentalDental1
MVLCord, RetractionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921601000ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINEUltradent Products, Inc.1992-06-16JES

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540172009959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540172009959075401720099597540172009959

GMDN Terms#

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

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length244Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature025 Degrees Celsius
Special Storage Condition, Specify00Keep away from heat, sparks and flame.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags#

DUNS number
626406016
Device count
1
Lot or batch
true

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07540172019712Evanesce™ Silk Nano-Enhanced Universal Restorative C2U Single Dose3235773235772024-09-17
07540172019729Evanesce™ Silk Nano-Enhanced Universal Restorative A2U Single Dose Sample9732119732112024-09-17
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