Catalog Number

-

Brand Name

Bite blocks 10pcs OP 3D

Version/Model Number

901013

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180947

Product Code

EHA

Product Code Name

Aligner, Beam, X-Ray

Public Device Record Key

f84c4785-638a-44c1-bda3-a6df68b80fa8

Public Version Date

June 03, 2021

Public Version Number

1

DI Record Publish Date

May 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-