Identity
- Trade Name
- LOCATOR EUDAMEDFDA UDI
- Generic Name
- Dental impression spacer FDA UDI
- Device Name
- LOCATOR Scan Body EUDAMEDSCAN BODY, LOCATOR (10 PACK) FDA UDI
- Model / Reference
- 09260-10 EUDAMEDFDA UDI
- Description
- SCAN BODY, LOCATOR (10 PACK) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840481127441 EUDAMEDFDA UDI
- Basic UDI-DI
- 08404811Z048EX EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental impression spacer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Locator by Zest Anchors, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08404811Z048EX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zest Anchors, LLC
- EUDAMED SRN
- US-MF-000009815
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 4ae87d54-ce29-4042-8b48-aae0f75b3e92 61 fields · synced Jul 18, 2026
- FDA UDI 144345e5-70d5-4245-a0fc-7b8f91757e0a 34 fields · synced May 30, 2026