Identity
- Trade Name
- NEW ACE EUDAMEDFDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Model / Reference
- 6*1SET,L10,L,A4 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- SSNEWXL10XLXA4 EUDAMEDD080SSNEWXL10XLXA40 FDA UDI
- Basic UDI-DI
- B-SSNEWXL10XLXA4 EUDAMED
- 510(k) Number
- K060507 FDA UDI
- FDA Product Code
- ELM FDA UDI
- EMDN Code
- Q01020601 MOBILE DENTAL PROSTHESES EUDAMED
- GMDN Term
- Resin artificial teeth FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3590 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Partial denture
New Ace by Yamahachi Dental Mfg., Co. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Partial denture.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-SSNEWXL10XLXA4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Yamahachi Dental Mfg., Co.
- EUDAMED SRN
- JP-MF-000024849
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 1e3f5a5b-b982-4fa4-b07a-b2439a8ee043 61 fields · synced May 31, 2026
- FDA UDI 4fff5fed-ed5d-4f54-8d89-653665a0e2d2 33 fields · synced May 30, 2026