Identity
- Trade Name
- Ionosphere FDA UDI
- Generic Name
- Dental amalgam FDA UDI
- Device Name
- Ionosphere 2 Spill 600mg Fast Set 500 jar FDA UDI
- Model / Reference
- 1002153 FDA UDI
- Description
- Ionosphere 2 Spill 600mg Fast Set 500 jar FDA UDI
Identifiers
- Catalog Number
- 1002153 FDA UDI
- Primary DI / UDI-DI
- H65810021531 FDA UDI
- 510(k) Number
- K821222 FDA UDI
- FDA Product Code
- EJJ FDA UDI
- GMDN Term
- Dental amalgam FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 600 Milligram FDA UDI
Category: Dental amalgam
Ionosphere by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental amalgam.
- Spherodon + — SILMET LTD · Class II
- Original D Capsules 1 Spill Fast Set 500 count — WYKLE RESEARCH, INC. · Class II
- ANA 2000 Capsules 2 Spill 450 count — WYKLE RESEARCH, INC. · Class II
- Spherodon M Econom — SILMET LTD · Class II
- Original D 1 spill amalgam regular set sample pack — WYKLE RESEARCH, INC. · Class II
- ANA 70 Capsules 1 Spill 450 count — WYKLE RESEARCH, INC. · Class II
- Dispersed Phase Alloy CAP Fast Set 2 SPILL — DARBY DENTAL SUPPLY, LLC · Class II
- Dispersed Phase Alloy CAP Regular Set 1 SPILL — DARBY DENTAL SUPPLY, LLC · Class II
Cleared under the same submission
K821222 also covers:
- Dispersed Phase Alloy CAP Fast Set 1 SPILL — DARBY DENTAL SUPPLY, LLC
- Dispersed Phase Alloy CAP Fast Set 2 SPILL — DARBY DENTAL SUPPLY, LLC
- Dispersed Phase Alloy CAP Fast Set 2 SPILL — DARBY DENTAL SUPPLY, LLC
- Dispersed Phase Alloy CAP Fast Set 3 SPILL — DARBY DENTAL SUPPLY, LLC
- Dispersed Phase Alloy CAP Fast Set 3 SPILL — DARBY DENTAL SUPPLY, LLC
- Dispersed Phase Alloy CAP Regular Set 1 SPILL — DARBY DENTAL SUPPLY, LLC
- Dispersed Phase Alloy CAP Regular Set 1 SPILL — DARBY DENTAL SUPPLY, LLC
- Dispersed Phase Alloy CAP Regular Set 2 SPILL — DARBY DENTAL SUPPLY, LLC
- Dispersed Phase Alloy CAP Regular Set 2 SPILL — DARBY DENTAL SUPPLY, LLC
- Dispersed Phase Alloy CAP Regular Set 3 SPILL — DARBY DENTAL SUPPLY, LLC
- Dispersed Phase Alloy CAP Regular Set 3 SPILL — DARBY DENTAL SUPPLY, LLC
- Ultra Dispersed Phase High Copper — DMG America LLC
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
- Henry Schein, Inc.
Sources (1)
- FDA UDI 855ba3dd-59e5-4e81-aff4-d2372b184a70 37 fields · synced May 30, 2026