Identity
- Trade Name
- Baltic Denture System BDLoad FDA UDI
- Generic Name
- Preformed complete denture FDA UDI
- Device Name
- Baltic Denture System BDLoad BDLoad High Impact upper Sm6 PLSEbm6DFs B2ECO pink FDA UDI
- Model / Reference
- Baltic Denture System BDLoad BDLoad High Impact upper Sm6 PLSEbm6DFs B2ECO pink FDA UDI
- Description
- Baltic Denture System BDLoad BDLoad High Impact upper Sm6 PLSEbm6DFs B2ECO pink FDA UDI
Identifiers
- Catalog Number
- 1034378 FDA UDI
- Primary DI / UDI-DI
- D7091034378 FDA UDI
- FDA Product Code
- EKO FDA UDI
- GMDN Term
- Preformed complete denture FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Preformed complete denture
The Baltic Denture System BDLoad is a prefabricated plastic plate designed to fit over an edentulous maxillary or mandibular alveolar ridge, creating a full denture with an entire complement of artificial teeth. Available in several standard sizes that can be contoured to custom fit the patient's ridge.
Similar devices
Also classified as Preformed complete denture.
- Good Fit Instant Overdentures — GOOD FIT TECHNOLOGIES, LLC · Class II
- Good Fit Instant Overdentures — GOOD FIT TECHNOLOGIES, LLC · Class II
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · U
- Baltic Denture System BD Load — Merz Dental GmbH · Class II
- Baltic Denture System BD Load — Merz Dental GmbH · Class II
- Baltic Denture System BDLoad — Merz Dental GmbH · Class II
- Baltic Denture System BD Load — Merz Dental GmbH · Class II
- Baltic Denture System BDLoad — Merz Dental GmbH · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Merz Dental GmbH
Sources (1)
- FDA UDI 04c86389-287e-4147-a0cc-595d5b1fec91 35 fields · synced Jul 26, 2026