FDA.reportPublic FDA data

Dryz™

Primary DI
00810000525577
Brand
Dryz™
Company
PARKELL, INC.
Model
S180-K
Catalog number
S180-K
Device description
Dryz™ Syringe Gingival Hemostatic Retraction Paste (Pkg. of 7 Syringes) for Korea
Published
2021-10-01
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVLCord, Retraction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVLCord, RetractionUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810000525574PrimaryGS10
00810000525577Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000052557410810000525574
00810000525577008100005255778100005255770810000525577

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, Specify00Refrigeration will prolong shelf life, but avoid freezing. Bring to room temperature before use.
Special Storage Condition, Specify00Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature3 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6312491134customerservice@parkell.com

Regulatory Flags#

DUNS number
009900424
Device count
7
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810000525799Predicta®D650D6502026-09-25
10810000525802Predicta®S651S6512026-09-25
M595S367UD1Epic®S367UDS367UD2016-09-23
M595S4130NAS413S4132016-09-23
00810000529568TotalBond®S413S4132018-11-23
00810000522729GentleCLEAN™DSG30GCPDSG30GCP2018-11-02
10810000527554Parkell®S276S2762018-10-19
M595S3930NAS393S3932016-09-23
M595S3940NAS394S3942016-09-23
M595S3950C&B METABOND®S395S3952016-09-23
00810000529070C&B METABOND®S394S3942018-11-23
00810000529193C&B METABOND®S393S3932018-11-23
00810000529209C&B METABOND®S395S3952018-11-23
00810000525294SmarTemp®S338S3382018-10-26
1081000052669420/20™S575S5752025-09-26
00810000525782HyperFIL®S235SPS235SP2025-09-26
00810000528271TriPhasix™S408S4082025-09-26
0081000052669720/20™S575S5752025-09-26
M595D6750Aurora™D675D6752016-09-24
00810000520053Parkell®D675D6752018-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08809370410233SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
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