510(k) K964038
- Device
- CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
- Applicant
- HERAEUS KULZER, INC.
- 510(k) number
- K964038
- Product code
- KLE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-02
- Date received
- 1996-10-04
- Regulation
- 872.3200
- Classification name
- Agent, Tooth Bonding, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHERYL ZIMMERMAN
- Address
- 4315 S Lafayette Blvd. South Bend IN US 46614 46614
FDA Registration Numbers#
- 3010664129
- 3011649314
- 3012421607
- 3013557697
- 9680845
- 2437780
- 9611385
- 3007584711
- 3015189878
- 2244812
- 2081055
- 1000272892
- 2018957
- 2183301
- 1013257
- 3017674095
- 8044164
- 3027616
- 3026400121
- 1718476
- 3012477813
- 3006694515
- 9612300
- 9681210
- 3005665377
- 3043226252
- 3032378317
- 3014683120
- 3008882689
- 3008524225
- 9610902
- 2022039
- 3014270094
- 9614573
- 1413399
- 3011689956
- 3014615644
- 1000625496
- 3009603151
- 2086043
- 2024312
- 3012187973
- 3035693034
- 3032027578
- 3013411964
- 3004425647
- 1420052
- 3018507299
- 3002808149
- 3004966444
- 2523320
- 2244842
- 9680144
- 3005628474
- 2424472
- 3002789526
- 3012627824
- 3044819802
- 3010864832
- 3000219976
- 3004140838
- 3003120666
- 9613375
- 2023950
- 1725006
- 3032163716
- 2014676
- 2429849
- 9681356
- 3002807050
- 2511556
- 3013584861
- 3009496224
- 2126683
- 8030067
- 3018283083
- 2433629
- 3039433962
- 8020994
- 2411797
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KLE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260485 | Any-Etch | Mediclus Co., Ltd. | 2026-05-14 |
| K260430 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | 2026-04-10 |
| K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | 2026-03-05 |
| K260682 | Bond-PR™ Universal Adhesive | Premier Dental Products Company | 2026-03-03 |
| K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026-02-23 |
| K252151 | els unibond | Saremco Dental AG | 2025-12-05 |
| K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. | 2025-11-06 |
| K251124 | G-Bond Universal | GC America, Inc. | 2025-10-02 |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. | 2024-11-08 |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | Spident Co., Ltd. | 2024-11-01 |
| K240153 | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd. | 2024-10-02 |
| K241445 | K-Bond Universal | Spident Co., Ltd. | 2024-07-22 |
| K241056 | Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd. | 2024-07-16 |
| K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024-03-20 |
Legacy Summary#
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FDA Review#
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