FDA.reportPublic FDA data

Impression Rekit (Medium)

Primary DI
00850017524040
Brand
Impression Rekit (Medium)
Company
STRAIGHT SMILE LLC
Model
BYTERKM
Device description
Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit
Published
2022-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EHYTray, Impression, Preformed
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017524040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017524040008500175240408500175240400850017524040

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material kit, single-useA collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis, orthodontic appliance, and/or oral appliance. The kit typically includes dental impression materials and a dental impression tray(s); reusable application devices are not included. Impression material is placed on the tray and the tray is then positioned in the mouth of the patient until the material becomes firm creating the mould. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8667652327support@byteme.com

Regulatory Flags#

DUNS number
081010579
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017524224Portable UV SanitizerBYTEUVS2023-03-20
00850017524163Byte Day AlignesHBYTETrayPRS-00632022-05-31
00850017524170Byte Night AlignersNBYTETrayPRS-00632022-05-31
00850017524187Byte RetainerBYTERetainerTrayPRS-00632022-05-31
00850017524200Brightbyte Pro (wireless) Whitening KitBYTEBBP22023-09-07
00850017524132ChewiesBCHW22022-06-02
00850017524064BrightBytebb2022-09-30
00850017524088Brightbyte Pro Whitening KitBYTEBBP2022-06-06
00850017524118Brightbyte Pro Refill PensBBPRP2022-06-06
00850017524002Smile StretcherBSS12022-06-02
00850017524019Impression Kit StandardKIT2022-06-02
00850017524033Impression Rekit (Small)BYTERKS2022-06-02
00850017524057Impression Rekit (Large) BYTERKL2022-06-02
00850017524149Retainer RetrieverBRR12022-06-02
00860000506007Byte Aligner SystemPRS-0063PRS-00632019-04-20

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