Identity
- Trade Name
- GINGIVA GAUGE FDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDI
- Model / Reference
- AGGM-M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800020849038 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implantation depth/angle gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implantation depth/angle gauge, reusable
Gingiva Gauge by SNUCONE Co., LTD. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implantation depth/angle gauge, reusable.
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- Tatum Socket Guide 4.5mm — SUNCOAST DENTAL, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SNUCONE Co., LTD.
Sources (2)
- FDA UDI 22a8397c-44e8-4fca-b1ee-ad775b33c7fe 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026