Identity
- Trade Name
- MacBite FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- MacBite Registration Material - 50ml, 10/Bx FDA UDI
- Model / Reference
- 12178 FDA UDI
- Description
- MacBite Registration Material - 50ml, 10/Bx FDA UDI
Identifiers
- Primary DI / UDI-DI
- D105121781 FDA UDI
- 510(k) Number
- K221668 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Silicone dental impression material
MacBite by Surgimac LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone dental impression material.
- Defend — Young Innovations, Inc. · Class II
- UPPER IMPRESSION TRAY (S) — Dental Expert · Class I
- Katalysator Paste 35 ml — DETAX GmbH & Co. KG · Class IIa
- Bonasil A+ Regular (FS) 50ml x 32 — DMP Dental Industry S.A. · Class I
- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Cleared under the same submission
K221668 also covers:
- Chemoment — Chemoment Materials Co., Ltd.
- Chemoment — Chemoment Materials Co., Ltd.
- Chemoment — Chemoment Materials Co., Ltd.
- Chemoment — Chemoment Materials Co., Ltd.
- Chemoment — Chemoment Materials Co., Ltd.
- Chemoment — Chemoment Materials Co., Ltd.
- Chemoment — Chemoment Materials Co., Ltd.
- Chemoment — Chemoment Materials Co., Ltd.
- Chemoment — Chemoment Materials Co., Ltd.
- Chemoment — Chemoment Materials Co., Ltd.
- Chemoment — Chemoment Materials Co., Ltd.
- EcoPression — MN Health, Inc
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
- Surgimac LLC
Sources (1)
- FDA UDI cfed298d-cf3c-4af0-a663-2dfae020cc58 34 fields · synced May 31, 2026