FDA UDI
In Commercial Distribution
🇺🇸 United States
Baltic Denture System BD Load
DI: D7091032200
·
Model: Baltic Denture System BDLoad Sm6 PLSEbm6DFs A3lightpink
·
Merz Dental GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Baltic Denture System BD Load
- Primary DI
- D7091032200
- Version / Model
- Baltic Denture System BDLoad Sm6 PLSEbm6DFs A3lightpink
- Catalog Number
- 1032200
- Company Name
- Merz Dental GmbH
- Labeler DUNS
- 324914910
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2025-01-27
- Public Version Status
- Update
- Public Device Record Key
- aa6660c3-255f-4bd4-8e76-8deb7b0bb91d
Device Description
Baltic Denture System BDLoad Sm6 PLSEbm6DFs A3lightpink
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKO | Denture Preformed (Partially Prefabricated Denture) | Dental | 872.3600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D7091032200 | HIBCC |
Customer Contacts
- Phone
- +494381403411
- [email protected]