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Monolith Spot-Indicator-Spray PLUS "green"
FDA UDIClass I (US FDA UDI)
by Prisman Inc.
Identity
- Trade Name
- Monolith Spot-Indicator-Spray PLUS "green" FDA UDI
- Generic Name
- Dental articulation paste/solution FDA UDI
- Model / Reference
- M403 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04064896000526 FDA UDI
- FDA Product Code
- EFH FDA UDI
- GMDN Term
- Dental articulation paste/solution FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6140 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: Dental articulation paste/solution
Monolith Spot-Indicator-Spray PLUS "green" by Prisman Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MacBite — Surgimac LLC · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Prisman Inc.
Sources (1)
- FDA UDI 3fb085ee-d68b-459a-8d99-977d6c5c6a15 32 fields · synced May 31, 2026