FDA.reportPublic FDA data

Splintastik

Primary DI
00842092168288
Brand
Splintastik
Company
Preat Corporation
Model
0200002
Catalog number
0200002
Device description
Splintastik Refill SM (6-Pack)
Published
2023-10-17
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGGAttachment, Precision, All

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092169988PrimaryGS10
00842092168288Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092169988008420921699888420921699880842092169988
00842092168288008420921682888420921682880842092168288

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 232-7732info@preat.com

Regulatory Flags#

DUNS number
117776048
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842092170199Preat9001230-109001230-102026-06-09
00842092174999Preat9003731-1009003731-1002026-06-09
00842092187722Preat7100033-27100033-22026-06-08
00842092116906Implant Prosthetics800125080012502016-09-16
00842092117217Implant Prosthetics800165080016502016-09-16
00842092117491Implant Prosthetics800055080005502016-09-16
00842092110669FR Attachments070204007020402023-07-05
00842092112076Preat06000F906000F92022-10-25
00842092112113Preat Implant Prosthetics0600F130600F132023-07-03
00842092122396Preat Implant Prosthetics800123780012372022-11-22
00842092155844Implantlink090751009075102022-10-25
00842092167601Preat0600F160600F162022-10-25
00842092167618Preat060406606040662022-10-25
00842092172544Preat010900301090032022-10-24
00842092172551Preat010900501090052022-10-24
00842092175590Preat010200701020072022-10-25
00842092175606Preat010200801020082022-10-25
00842092176696Preci-Clix01004TI01004TI2022-10-27
00842092110577Mays020006002000602023-10-17
00842092110737Splintastik020000102000012023-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H0005KX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2026-05-08
H0005TX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2026-05-08
ESTOI0107K5000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-10-14
ESTOV0003X2600StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-10-08
ESTOI6501K3000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-05-22
ESTOI6501K4500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-05-22
00842092110577MaysPreat CorporationEGG2023-10-17
00842092110737SplintastikPreat CorporationEGG2023-10-17
18056039211336NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211503NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211510NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211527NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
07640166516125Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093121Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093145Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093268Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
ESTOH0004K20StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004K30StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004K40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004X20StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004Z10StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOU0001Z315K0StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOV0001X2500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOV0001Z3000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
00842092109281Preci 52Preat CorporationEGG2023-07-06
00842092110669FR AttachmentsPreat CorporationEGG2023-07-05
00842092109328Preci 52Preat CorporationEGG2023-06-20
00842092110652Precision AttachmentsPreat CorporationEGG2023-05-19
07630031758743NAInstitut Straumann AGEGG2022-12-02
07630031758750NAInstitut Straumann AGEGG2022-12-02