AccessGUDID - DEVICE: Baltic Denture System BDLoad (D7091035043)

GUDID

Device Identifier (DI) Information

Brand Name: Baltic Denture System BDLoad
Version or Model: Baltic Denture System BDLoad BDLoad High Impact lower Mn6 PLSEum2DFm C1ECO pink
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1035043
Company Name: Merz Dental GmbH

Primary DI Number: D7091035043
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324914910 *Terms of Use

Device Description: Baltic Denture System BDLoad BDLoad High Impact lower Mn6 PLSEum2DFm C1ECO pink

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11172	Preformed complete denture	A prefabricated plastic plate designed to fit over an edentulous maxillary or mandibular alveolar ridge; an entire complement of artificial teeth from one arch is added to create a full denture. It is available in several standard sizes that can be contoured to custom fit the patient's ridge.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKO	Denture Preformed (Partially Prefabricated Denture)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d0692e2d-484e-470b-8807-69da438ecd75
Public Version Date: October 09, 2019
Public Version Number: 1
DI Record Publish Date: October 01, 2019