Vitalescence
510(k) K974282
Vitalescence is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K974282 on 29 Jan 1998, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974282 | Date29 Jan 1998 | StatusActive |
Official records
- FDA 510(k) database K974282
Recalls
-
- Ongoing Z-3066-2024
Due to a manufacturing issue, red particulates present in the expressed composite.
Timeline
- Cleared FDA 510(k) K974282
- Recall initiated FDA recalls Z-3066-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K974282
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Direct Composite S130- | S130- / S130- | 00883205015570 | On the market | |
| Vit-l-escence 1182 | 1182 / 1182 | 00883205105967 | On the market | |
| Vit-l-escence 1185 | 1185 / 1185 | 00883205105998 | On the market | |
| Vit-l-escence 1187 | 1187 / 1187 | 00883205106018 | On the market | |
| Vit-l-escence 1188 | 1188 / 1188 | 00883205106025 | On the market | |
| Vit-l-escence 1189 | 1189 / 1189 | 00883205106032 | On the market | |
| Vit-l-escence 1197 | 1197 / 1197 | 00883205106063 | On the market | |
| Vit-l-escence 1198 | 1198 / 1198 | 00883205106070 | On the market | |
| Vit-l-escence 1202 | 1202 / 1202 | 00883205106087 | On the market | |
| Vit-l-escence 1203 | 1203 / 1203 | 00883205106094 | On the market | |
| Vit-l-escence 1204 | 1204 / 1204 | 00883205106100 | On the market | |
| Vit-l-escence 1205 | 1205 / 1205 | 00883205106117 | On the market | |
| Vit-l-escence 1220 | 1220 / 1220 | 00883205106155 | On the market | |
| Vit-l-escence 1227 | 1227 / 1227 | 00883205106179 | On the market | |
| Vit-l-escence 1228 | 1228 / 1228 | 00883205106186 | On the market | |
| Vit-l-escence 1229 | 1229 / 1229 | 00883205106193 | On the market | |
| Vit-l-escence 1317 | 1317 / 1317 | 00883205106216 | On the market | |
| Vit-l-escence 2230 | 2230 / 2230 | 00883205106339 | On the market | |
| Vit-l-escence 2231 | 2231 / 2231 | 00883205106346 | On the market | |
| Vit-l-escence 2233 | 2233 / 2233 | 00883205106360 | On the market | |
| Vit-l-escence 2234 | 2234 / 2234 | 00883205106377 | On the market | |
| Vit-l-escence 2235 | 2235 / 2235 | 00883205106384 | On the market | |
| Vit-l-escence 2236 | 2236 / 2236 | 00883205106391 | On the market | |
| Vit-l-escence 2237 | 2237 / 2237 | 00883205106407 | On the market | |
| Vit-l-escence 2238 | 2238 / 2238 | 00883205106414 | On the market | |
| Vit-l-escence 2240 | 2240 / 2240 | 00883205106438 | On the market | |
| Vit-l-escence 2241 | 2241 / 2241 | 00883205106445 | On the market | |
| Vit-l-escence 2242 | 2242 / 2242 | 00883205106452 | On the market | |
| Vit-l-escence 2243 | 2243 / 2243 | 00883205106469 | On the market | |
| Vit-l-escence 2244 | 2244 / 2244 | 00883205106476 | On the market | |
| Vit-l-escence 2245 | 2245 / 2245 | 00883205106483 | On the market | |
| Vit-l-escence 2246 | 2246 / 2246 | 00883205106490 | On the market | |
| Vit-l-escence 2248 | 2248 / 2248 | 00883205106513 | On the market | |
| Vit-l-escence 343 | 343 / 343 | 00883205105530 | On the market | |
| Vit-l-escence 356 | 356 / 356 | 00883205101280 | On the market | |
| Vit-l-escence 358 | 358 / 358 | 00883205105561 | On the market | |
| Vit-l-escence 362 | 362 / 362 | 00883205105592 | On the market | |
| Vit-l-escence 408 | 408 / 408 | 00883205105622 | On the market | |
| Vit-l-escence 409 | 409 / 409 | 00883205105639 | On the market | |
| Vit-l-escence 418 | 418 / 418 | 00883205105646 | On the market | |
| Vit-l-escence 421 | 421 / 421 | 00883205105653 | On the market | |
| Vit-l-escence 422 | 422 / 422 | 00883205105660 | On the market | |
| Vit-l-escence 423 | 423 / 423 | 00883205105677 | On the market | |
| Vit-l-escence 426 | 426 / 426 | 00883205105684 | On the market | |
| Vit-l-escence 435 | 435 / 435 | 00883205105691 | On the market | |
| Vit-l-escence 442 | 442 / 442 | 00883205105738 | On the market | |
| Vit-l-escence 443 | 443 / 443 | 00883205105745 | On the market | |
| Vit-l-escence 486 | 486 / 486 | 00883205105790 | On the market | |
| Vit-l-escence 499 | 499 / 499 | 00883205105806 | On the market | |
| Vit-l-escence 515 | 515 / 515 | 00883205105813 | On the market |
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