FDA.reportPublic FDA data

Mach-SLO™

Primary DI
10810000524102
Brand
Mach-SLO™
Company
PARKELL, INC.
Model
S430S
Catalog number
S430S
Device description
Mach-SLO™ Die Silicone Material
Published
2019-08-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810000524102PrimaryGS10
00810000524105Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000052410210810000524102
00810000524105008100005241058100005241050810000524105

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid excessive heat, light, or moisture
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature18 Degrees Celsius24 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6312491134customerservice@parkell.com

Regulatory Flags#

DUNS number
009900424
Device count
2
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810000522934DuraTip®DURA30-PSLDURA30-PSL2025-07-18
00810000522941DuraTip®DURA30-PSRDURA30-PSR2025-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816394021855Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021930Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021947Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021954Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021985Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021992Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022005Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022012Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022050Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022067Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022074Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022081Helmer ScientificHELMER, INC.LXG2026-05-13
15099590695743iChemVELOCITYBECKMAN COULTER IRELAND INC.LXG2026-04-27
09120123910022Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
26974573531033CellproSuzhou CellPro Biotechnology Co., Ltd.LXG2025-11-21
10818207025071Endocator Starter KitVista DentalLXG2025-11-07
10818207025088Endocator Swabs (20pk)Vista DentalLXG2025-11-07
00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050283KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050306KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050511KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050528KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050535KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050542KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050559KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050603KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050610KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100051297KBMEDKB Medical (group), Inc.LXG2025-05-22
20885380197861CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18
20885380197878CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18