Intrigue
Intrg Whisp-Z Roth CUS HK -11T +5A 018 LR
1manufacturer
253catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi TP Orthodontics Material Co., Ltd. | Wuxi | Jiangsu | Repacker / relabeller | 9 |
Record
| Listed by | Lancer Orthodontics, Inc., United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Record published | 2016-12-03 |
| Record revised | 2022-04-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 231-211 | In distribution | |
| 230-023 | In distribution | |
| 230-224 | In distribution | |
| 231-112 | In distribution | |
| 231-521 | In distribution | |
| 231-172 | In distribution | |
| 231-052 | In distribution | |
| 230-072 | In distribution | |
| 230-102 | In distribution | |
| 230-171 | In distribution | |
| 230-022 | In distribution | |
| 231-031 | In distribution | |
| 230-101 | In distribution | |
| 231-102 | In distribution | |
| 231-061 | In distribution | |
| 231-101 | In distribution | |
| 231-133 | In distribution | |
| 246-002 | In distribution | |
| 231-051 | In distribution | |
| 231-533 | In distribution | |
| 230-223 | In distribution | |
| 231-323 | In distribution | |
| 231-362 | In distribution | |
| 231-573 | In distribution | |
| 245-103 | In distribution | |
| 231-223 | In distribution | |
| 246-171 | In distribution | |
| 231-232 | In distribution | |
| 230-051 | In distribution | |
| 230-251 | In distribution | |
| 231-512 | In distribution | |
| 231-322 | In distribution | |
| 230-033 | In distribution | |
| 231-033 | In distribution | |
| 246-102 | In distribution | |
| 231-324 | In distribution | |
| 246-011 | In distribution | |
| 246-071 | In distribution | |
| 246-351 | In distribution | |
| 230-021 | In distribution | |
| 246-061 | In distribution | |
| 245-101 | In distribution | |
| 246-012 | In distribution | |
| 231-271 | In distribution | |
| 230-332 | In distribution | |
| 230-372 | In distribution | |
| 231-123 | In distribution | |
| 245-004 | In distribution | |
| 231-331 | In distribution | |
| 231-261 | In distribution | |
| 246-251 | In distribution | |
| 246-173 | In distribution | |
| 231-501 | In distribution | |
| 231-012 | In distribution | |
| 230-172 | In distribution | |
| 230-061 | In distribution | |
| 230-002 | In distribution | |
| 230-054 | In distribution | |
| 230-341 | In distribution | |
| 246-031 | In distribution | |
| 230-302 | In distribution | |
| 231-402 | In distribution | |
| 230-221 | In distribution | |
| 231-222 | In distribution | |
| 230-361 | In distribution | |
| 230-122 | In distribution | |
| 230-031 | In distribution | |
| 231-173 | In distribution | |
| 230-123 | In distribution | |
| 231-502 | In distribution | |
| 230-263 | In distribution | |
| 230-012 | In distribution | |
| 231-451 | In distribution | |
| 230-262 | In distribution | |
| 230-324 | In distribution | |
| 231-132 | In distribution | |
| 230-154 | In distribution | |
| 230-253 | In distribution | |
| 230-254 | In distribution | |
| 231-073 | In distribution | |
| 231-124 | In distribution | |
| 231-171 | In distribution | |
| 230-362 | In distribution | |
| 230-312 | In distribution | |
| 230-024 | In distribution | |
| 246-312 | In distribution | |
| 246-111 | In distribution | |
| 231-433 | In distribution | |
| 230-111 | In distribution | |
| 231-272 | In distribution | |
| 230-121 | In distribution | |
| 231-551 | In distribution | |
| 231-302 | In distribution | |
| 230-032 | In distribution | |
| 231-412 | In distribution | |
| 245-104 | In distribution | |
| 231-254 | In distribution | |
| 231-162 | In distribution | |
| 246-065 | In distribution | |
| 246-321 | In distribution | |
| 246-322 | In distribution | |
| 230-053 | In distribution | |
| 230-363 | In distribution | |
| 230-201 | In distribution | |
| 246-223 | In distribution | |
| 231-111 | In distribution | |
| 246-073 | In distribution | |
| 246-033 | In distribution | |
| 231-463 | In distribution | |
| 246-301 | In distribution | |
| 231-151 | In distribution | |
| 246-001 | In distribution | |
| 231-233 | In distribution | |
| 231-163 | In distribution | |
| 230-333 | In distribution | |
| 230-161 | In distribution | |
| 230-173 | In distribution | |
| 230-211 | In distribution | |
| 231-121 | In distribution | |
| 230-353 | In distribution | |
| 246-311 | In distribution | |
| 230-261 | In distribution | |
| 230-011 | In distribution | |
| 230-124 | In distribution | |
| 246-161 | In distribution | |
| 231-241 | In distribution | |
| 231-312 | In distribution | |
| 245-102 | In distribution | |
| 230-062 | In distribution | |
| 230-232 | In distribution | |
| 246-211 | In distribution | |
| 231-321 | In distribution | |
| 246-323 | In distribution | |
| 230-162 | In distribution | |
| 231-202 | In distribution | |
| 230-351 | In distribution | |
| 231-441 | In distribution | |
| 246-353 | In distribution | |
| 230-152 | In distribution | |
| 230-352 | In distribution | |
| 230-222 | In distribution | |
| 230-071 | In distribution | |
| 230-252 | In distribution | |
| 231-363 | In distribution | |
| 245-001 | In distribution | |
| 246-201 | In distribution | |
| 246-063 | In distribution | |
| 230-131 | In distribution | |
| 231-021 | In distribution | |
| 231-422 | In distribution | |
| 246-202 | In distribution | |
| 230-272 | In distribution | |
| 246-163 | In distribution | |
| 231-372 | In distribution | |
| 230-321 | In distribution | |
| 231-353 | In distribution | |
| 246-254 | In distribution | |
| 230-241 | In distribution | |
| 230-041 | In distribution | |
| 230-231 | In distribution | |
| 231-022 | In distribution | |
| 231-354 | In distribution | |
| 246-241 | In distribution | |
| 246-341 | In distribution | |
| 230-151 | In distribution | |
| 231-152 | In distribution | |
| 231-032 | In distribution | |
| 231-333 | In distribution | |
| 231-063 | In distribution | |
| 231-212 | In distribution | |
| 231-552 | In distribution | |
| 246-252 | In distribution | |
| 231-253 | In distribution | |
| 245-002 | In distribution | |
| 231-263 | In distribution | |
| 230-371 | In distribution | |
| 231-563 | In distribution | |
| 246-302 | In distribution | |
| 246-324 | In distribution | |
| 230-323 | In distribution | |
| 231-221 | In distribution | |
| 230-052 | In distribution | |
| 230-163 | In distribution | |
| 231-141 | In distribution | |
| 231-411 | In distribution | |
| 246-212 | In distribution | |
| 231-122 | In distribution | |
| 231-473 | In distribution | |
| 230-141 | In distribution | |
| 230-271 | In distribution | |
| 231-373 | In distribution | |
| 231-071 | In distribution | |
| 231-301 | In distribution | |
| 231-452 | In distribution | |
| 231-153 | In distribution | |
| 230-153 | In distribution | |
| 231-231 | In distribution | |
| 246-133 | In distribution | |
| 246-253 | In distribution | |
| 230-311 | In distribution | |
| 231-522 | In distribution | |
| 231-201 | In distribution | |
| 246-131 | In distribution | |
| 230-301 | In distribution | |
| 230-233 | In distribution | |
| 231-371 | In distribution | |
| 231-361 | In distribution | |
| 231-251 | In distribution | |
| 246-221 | In distribution | |
| 230-354 | In distribution | |
| 245-003 | In distribution | |
| 231-072 | In distribution | |
| 231-001 | In distribution | |
| 230-373 | In distribution | |
| 230-063 | In distribution | |
| 230-273 | In distribution | |
| 231-332 | In distribution | |
| 231-054 | In distribution | |
| 231-351 | In distribution | |
| 230-132 | In distribution | |
| 230-073 | In distribution | |
| 231-024 | In distribution | |
| 231-262 | In distribution | |
| 231-154 | In distribution | |
| 231-011 | In distribution | |
| 246-352 | In distribution | |
| 231-273 | In distribution | |
| 231-541 | In distribution | |
| 231-023 | In distribution | |
| 231-352 | In distribution | |
| 246-101 | In distribution | |
| 231-341 | In distribution | |
| 231-401 | In distribution | |
| 231-062 | In distribution | |
| 246-354 | In distribution | |
| 231-311 | In distribution | |
| 230-133 | In distribution | |
| 231-002 | In distribution | |
| 231-053 | In distribution | |
| 231-252 | In distribution | |
| 246-222 | In distribution | |
| 230-212 | In distribution | |
| 231-511 | In distribution | |
| 246-112 | In distribution | |
| 230-331 | In distribution | |
| 231-421 | In distribution | |
| 230-322 | In distribution | |
| 230-112 | In distribution | |
| 231-131 | In distribution | |
| 230-202 | In distribution |
Showing 250 of 253 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QuicKlear® | Forestadent Bernhard Förster GmbH | 841 |
| Bracket, Ceramic, Orthodontic | Flexmedics | 600 |
| Experience | GC Orthodontics America Inc. | 500 |
| TruKlear | Forestadent Bernhard Förster GmbH | 401 |
| Chic | GC Orthodontics America Inc. | 348 |
| Bracket, Ceramic, Orthodontic | Forestadent Bernhard Förster GmbH | 342 |
| IN-Ovation® C | Dentsply Sirona Orthodontics Inc. | 327 |
| Empower Clear | American Orthodontics | 250 |
| Empower Clear Bracket | American Orthodontics | 250 |
| InVu Ceramic Brackets | TP Orthodontics, Inc. | 226 |
| RadiancePlus | American Orthodontics | 179 |
| InVu Readi-Base Brackets | TP Orthodontics, Inc. | 173 |
Showing 12 of 399. All products under Bracket, Ceramic, Orthodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K902075 | 1990-08-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.