Identity
- Trade Name
- PATTERSON FDA UDI
- Generic Name
- Dental amalgam alloy FDA UDI
- Device Name
- PD ADMIX 2SP REG SPL FDA UDI
- Model / Reference
- 090900151 FDA UDI
- Description
- PD ADMIX 2SP REG SPL FDA UDI
Identifiers
- Primary DI / UDI-DI
- D6620909001512 FDA UDI
- 510(k) Number
- K801639 FDA UDI
- FDA Product Code
- EJJ FDA UDI
- GMDN Term
- Dental amalgam alloy 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental amalgam alloy
Patterson by Patterson Dental Supply, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental amalgam alloy.
- PERMITE — Sdi , Ltd. · Class II
- GS80 — Sdi , Ltd. · Class II
- GS80 — Sdi , Ltd. · Class II
- PERMITE — Sdi , Ltd. · Class II
- LOJIC+ — Sdi , Ltd. · Class II
- LOJIC+ — Sdi , Ltd. · Class II
- PERMITE — Sdi , Ltd. · Class II
- LOJIC+ — Sdi , Ltd. · Class II
Cleared under the same submission
K801639 also covers:
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- GS80 — Sdi , Ltd.
- GS80 — Sdi , Ltd.
- GS80 — Sdi , Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Patterson Dental Supply, Inc.
Sources (1)
- FDA UDI 354d388d-3666-4b3b-ad33-6e94b67d66da 35 fields · synced May 31, 2026